Document Controller

About MeiraGTx

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

Purpose of Job

Act as the QA Documentation Controller for the business, ensuring that files stored and archived both within the electronic Quality Management System (eQMS; MasterControl) and outside of the eQMS are maintained appropriately according to relevant procedures.

Support validation of the MasterControl system to assure compliance across all sites; supporting project and upgrade re-qualification activities.

Provide first line support to end users for the MasterControl system, providing training as required.

Support the Quality Assurance team in other activities where requested.

Major Activities

  • Perform daily administrative tasks for the MasterControl System, including, but not limited to:
    • User Management
    • Document Review, Approval & Release
    • Reviewing Batch documentation
    • Setup and maintain training courses and curriculum
    • Workflow Management
    • User Support
    • eQMS and Document support during Regulatory, Competent authority and Third-Party audits.
    • Issuance of Batch Manufacturing Records and Batch Numbers.
    • Hard Copy Document Retention and Archiving.
    • Organise and manage QA Document Control visibility and activities.
  • Author and maintain procedural documents related to management of documents within the QMS
  • Maintain documentation held externally from the QMS, including document issue, return and archiving as required
  • Support QMS projects, including partaking in computer system validation activities where required
  • Develop and deliver training related to the QMS and any other role related training as required
  • Support Periodic System Reviews as required
  • Provide Key Performance Indicator Reports for departments as required.

Key Performance Indicators

  • The MasterControl document control system is maintained in a validated state
  • General MasterControl administrative tasks are completed contemporaneously e.g. users are provided with access when applicable, documents are reviewed and approved in a timely manner to facilitate the progression of GxP activities
  • All users are appropriately trained and supported when using the MasterControl Software.
  • Documentation maintained outside of the MasterControl system is maintained in an easily retrievable state
  • Any records overdue as escalated appropriately to facilitate progression
  • Attend any required training as defined by line manager
  • Metrics Reports are accurate and provided in a contemporaneous manner as required

Key Job Competencies

  • Experience in working with electronic Quality Management Systems for document and process management
  • Fully computer literate, proficient with standard software packages on an advanced level (such as Microsoft applications, specifically Excel, Word, PowerPoint) and adaptable to new software packages / web applications
  • Experience in developing and delivering end user training, preferred system training
  • Excellent interpersonal skills
  • Good organisational and time management skills and able to demonstrate flexibility and adaptability
  • Experience working with high volumes of documentation, electronic and paper
  • Good attention to detail for data entry tasks and understanding of Good Documentation Practices
  • A basic understanding of computer system validation in the pharmaceutical sector
  • Experience and knowledge of working in a regulated environment, specifically with regards to record retention
  • Knowledge of GCP and GMP with regards to QMS activities

Job Responsibilities

  • No direct reports

Job Background

  • Minimum of 3 years experience working in a GxP environment
  • IT literate, experience managing and operating an electronic QMS
  • English language required

Senior Manager of Regulatory Affairs

About MeiraGTx

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

Job Description

MeiraGTx is seeking a Senior Manager of Regulatory Affairs to be based in its New York City headquarters (remote to start, thereafter partially remote). The incumbent will primarily serve as a regulatory representative, initially working with senior regulatory team members, on one or more clinical phase programs in collaboration with the greater regulatory team. The role is intended for a proactive and flexible regulatory professional with the ability to support activities required to progress our novel therapeutic program(s) to registration. The Senior Manager will report directly to the Director of Regulatory Affairs and support the Regulatory Affairs team in various capacities. He/she will be responsible for co-developing and executing regulatory plans for assigned programs together with the greater regulatory team, and as a subject matter expert, will be relied upon to articulate clear and compelling regulatory strategy, highlighting risks and opportunities, when appropriate.

Key Responsibilities

  • Co-develops and implements innovative global regulatory strategies together with the greater regulatory team for assigned programs through collaboration with a cross functional project team and consensus-building with internal and external stakeholders.
  • Leads team in the development and execution of key deliverables to support regulatory submission strategies and planning, coordination, and preparation for successful interactions with regulatory authorities, together with the greater regulatory team.
  • Effectively communicates the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs management as needed
  • Maintains awareness of the evolving regulatory landscape and advises team and management of changes with potential strategic impact to future development. Interprets regulations, guidelines, and policy statements on a global level
  • Coordinates timely submissions to health authorities and monitors reporting requirements to maintain compliance with applicable regulations where needed
  • Interact with company partners and consultants for various regulatory matters, as needed

Qualifications

  • Bachelor’s or Master’s degree in life sciences with ~3–5 years of pharmaceutical/biotechnology industry experience in Regulatory Affairs; Advanced degree (PhD, PharmD) preferred
  • Experience in the preparation and successful submissions of regulatory submissions in key ICH regions (e.g. US INDs, Canadian and EU CTAs, etc.)
  • Experience interfacing with FDA and/or other global Health Authorities
  • Strong leadership and project management skills, including demonstrated cross-functional communication, negotiation and conflict management skills
  • Ability to represent regulatory affairs group in project teams, committees, and external meetings, as well as with partners and collaborators
  • Comprehensive working knowledge of applicable regulations in ICH regions and solid knowledge of GCPs and GLPs
  • Travel: minimal travel may be expected

QA Validation

About MeiraGTx

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

Purpose of Job

To provide QA Vaidation and Qualification technical support and oversight for the manufacture and supply of Advanced Therapies Medicinal Products (Gene Therapy viral vectors).

This is a key role in;

The QA Validation will play a key role as part of the MGTX Ireland Peoject team providing hands on and “boots on the ground” QA technical support and oversight to Qualificatin and Validation activities of the Manufacturing facility and Laboratories, ensuring that processes and equipment are appopiiately valiated and qualified in accordance with applicable Irish, EU and FDA regulations and MeiraGTx QMS.

Major Activities

  • Prepare and Maintenance of the Irish  site validation plan for MeiraGTx
  • Maintenance and archiving of Validation/qualificaiton documentation
  • Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure that validation project plans are understood and in keeping with site objectives.
  • Clearly communicate and/or provide training in the required validation standard to both the Meira staff and contractors
  • Review and approve validation, qualification protocols and reports
  • Define and mange as system for project related Deviations and Charge
  • Maintain understanding of cGMP, Good engineering practices and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
  • Support generation of Process and QC Equipment Installation, and Operational and Performance Qualifications, review and approve the Qualification protocols, discrepancies and reports for Quality.
  • Interface with external consultants and partners as directed by QA Validation and Materials Supply Manager, suppliers and contractors to ensure successful process and equipment validation. Provide QA support to data integrity compliance activities across the site.Write or assist in writing of MeiraGTx Policies, SOPs, work instructions and forms for validation requirements and other quality systems as required.  Support Regulatory Inspections and third party audits.
  • Ensure own work complies with GxP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents
  • Ensure own training is undertaken in a timely and compliant manner before the task is undertaken

Responsibilities

  • To support the implementation “best practice” in validation for a new GMP Gene Therapy manufacturing facility ensuring validation of the processes, and equipment meets applicable regulatory requirements.
  • To effectively guide the implementation of the Site Validation Master Plan, working with the engineering, operations and QC teams to oversee the commissioning; qualification and validation of the manufacturing facility and supporting activities.
  • Participate in risk assessments to develop process validation plans and protocols with Develeopment, Operations and QC staff.
  • Implement robust and ‘fit for purpose’ validation procedures ensuring the facility, equipment, and processes are validated, qualified and maintained to regulatory requirements.
  • All responsibilities are performed in a timely manner, escalating any and all issues to senior management as and when they occur.Describe Expectations
  • Recommend improvement in validation management practices and documents.

Key Job Competencies

  • The individual must have an established track record in delivering robust and regulatory compliant Validation Plans and Protocols
  • Extensive experience of GxP compliance requirements.
  • Able to Interact with other departments and personnel across the business both orally and in writing, demonstrating good interpersonal skills. \\
  • Can identify and escalate issues to line management, to ensure workload is prioritised, issues are highlighted to ensure business needs are met.
  • Able to respond flexibly and adapt to the needs of the department/wider business, demonstrating good organisational and time management skills. List key competencies to fulfil role

Job Responsibilities

  • Number of direct Reports – 0 (will change over time)
  • Financial authority – 0 (will change over time)

Job Background Education

  • BSC in Science / Engineering
  • Languages – English

Experience

  • Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within sterile manufacturing
  • Extensive experience with providing QA technical support and oversight to validation and qualification activities and with and implementing the concepts, legislation, guidelines and requirements related to qualification and validation of sterile products, aseptic processes, equipment and systems, including Computer System Validation e.g. EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11 & CFR Part 11 and ICH Q9
  • Knowledge of cell culture-based manufacturing techniques and requirements and cellular and gene therapies
  • Experience in using risk assessment tools including FMEA
  • Ability to balance needs of the business with the needs of the Regulatory challenges
  • Proven ability to work successfully in an ambitious, deadline-driven environment and handle multiple tasks simultaneously

QA Validation Lead

About MeiraGTx

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

Purpose of Job

To provide QA Vaidation and Qualification technical support and oversight for the manufacture and supply of Advanced Therapies Medicinal Products (Gene Therapy viral vectors).

This is a key role in;

The QA Validation Lead will play a key role as part of the MGTX Ireland Peoject team providing hands on and “boots on the ground” QA technical support and oversight to Qualificatin and Validation activities of the Manufacturing facility and Laboratories, ensuring that processes and equipment are appopiiately valiated and qualified in accordance with applicable Irish, EU and FDA regulations and MeiraGTx QMS.

Major Activities

  • Prepare and Maintenance of the Irish  site validation plan for MeiraGTx.
  • Maintenance and archiving of Validation/qualificaiton documentation
  • Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure that validation project plans are understood and in keeping with site objectives.
  • Clearly communicate and/or provide training in the required validation standard to both the Meira staff and contractors
  • Review and approve validation, qualification protocols and reports
  • Define and mange as system for project related Deviations and Charge
  • Maintain understanding of cGMP, Good engineering practices and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
  • Support generation of Process and QC Equipment Installation, and Operational and Performance Qualifications, review and approve the Qualification protocols, discrepancies and reports for Quality.
  • Interface with external consultants and partners as directed by QA Validation and Materials Supply Manager, suppliers and contractors to ensure successful process and equipment validation. Provide QA support to data integrity compliance activities across the site.Write or assist in writing of MeiraGTx Policies, SOPs, work instructions and forms for validation requirements and other quality systems as required.  Support Regulatory Inspections and third party audits.
  • Ensure own work complies with GxP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents
  • Ensure own training is undertaken in a timely and compliant manner before the task is undertaken

Responsibilities

  • To support the implementation “best practice” in validation for a new GMP Gene Therapy manufacturing facility ensuring validation of the processes, and equipment meets applicable regulatory requirements.
  • To effectively guide the implementation of the Site Validation Master Plan, working with the engineering, operations and QC teams to oversee the commissioning; qualification and validation of the manufacturing facility and supporting activities.
  • Participate in risk assessments to develop process validation plans and protocols with Develeopment, Operations and QC staff.
  • Implement robust and ‘fit for purpose’ validation procedures ensuring the facility, equipment, and processes are validated, qualified and maintained to regulatory requirements.
  • All responsibilities are performed in a timely manner, escalating any and all issues to senior management as and when they occur.Describe Expectations
  • Recommend improvement in validation management practices and documents.

Key Job Competencies

  • The individual must have an established track record in delivering robust and regulatory compliant Validation Plans and Protocols
  • Extensive experience of GxP compliance requirements.
  • Able to Interact with other departments and personnel across the business both orally and in writing, demonstrating good interpersonal skills.
  • Can identify and escalate issues to line management, to ensure workload is prioritised, issues are highlighted to ensure business needs are met.
  • Able to respond flexibly and adapt to the needs of the department/wider business, demonstrating good organisational and time management skills. List key competencies to fulfil role

Job Responsibilities

  • Number of direct Reports – 0 (will change over time)
  • Financial authority – 0 (will change over time)

Job Background Education

  • BSC in Science / Engineering
  • Languages – English

Experience

  • Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within sterile manufacturing
  • Extensive experience with providing QA technical support and oversight to validation and qualification activities and with and implementing the concepts, legislation, guidelines and requirements related to qualification and validation of sterile products, aseptic processes, equipment and systems, including Computer System Validation e.g. EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11 & CFR Part 11 and ICH Q9
  • Knowledge of cell culture-based manufacturing techniques and requirements and cellular and gene therapies
  • Experience in using risk assessment tools including FMEA
  • Ability to balance needs of the business with the needs of the Regulatory challenges
  • Proven ability to work successfully in an ambitious, deadline-driven environment and handle multiple tasks simultaneously

Senior Quality Assurance Associate

About MeiraGTx

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

Purpose of Job

Providing QA support and oversight at MeiraGTx

Ensuring QA regulatory compliance and product quality requirements are met at all times, as well as facilitating product release in a timely manner.

Coach and train the QA team and continuously improve the local Quality system and provide training & support for Quality relevant systems.

Major Activities and Responsibilities:

  • Provide QA oversight to the manufacturing operation and supporting functions
  • Management of the MeiraGTx Quality Management System
  • Generation, Review and approval of relevant GMP documentation.
  • Create QA Processes. Create Standard Operating Procedures, Policies and Training material.
  • Maintain QA KPI metrics.
  • Collaborate with Operational areas, supporting the Team Lead to manage the day-to-day QA Operations
  • Review Batch documentation and support QA team review of Batch documentation. Ensuring timely and adequate release of GMP compliant product in accordance with Regulatory and site-specific authorisations.
  • Manage and support QA team Facility walk rounds and QA support for all operational areas.
  • Provide direct quality team support during customer and regulatory audits.
  • Perform internal audits and inspections and audit write up.
  • Quality Systems: Complete Reporting, reviewing, investigating, root cause analysis, assessing Quality risk assessments, Incidents, Deviations, CAPA’s, Change Controls and temperature excursions.
  • Create and review Risk reporting and Mitigation.
  • Support Document Management activities when required.
  • Proactively initiate and support continuous improvement of the Quality Management System.
  • Deliver compliance training to operational areas.

Key Job Competencies

  • Experience of working within a sterile GMP manufacturing environment.
  • Excellent understanding of Quality Management Systems.
  • Proficient in Microsoft Office and experience in database use and eQMS systems.
  • Excellent interpersonal skills
  • Good organisational and time management skills and able to demonstrate flexibility and adaptability.
  • Able to prioritise workload, decisive thinker able to work within agreed timescales.
  • A high Level of attention to detail.
  • Knowledge of GCP and GMP with regards to QMS activities
  • Good team player and must also be able to work alone.
  • Experience in Competent authority, Regulatory body inspections and audits.

Job Responsibilities

  • Support the training and coaching of the QA operations team

Job Background

  • Experience working in a GxP environment including a minimum 5 years’ experience in Compliance and Quality Assurance.
  • IT literate, experience managing and operating an electronic QMS
  • Excellent verbal and written communication skills

Director, CMC Lead, Regulatory Affairs

About MeiraGTx

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

Purpose of Job

The CMC Director is responsible for overseeing the development and implementation of global regulatory CMC strategies for all gene therapy product development. The Director will provide regulatory CMC leadership across projects, teams and committees and will provide strategic and operational leadership for regulatory CMC activities including submissions, reviews, and health authority interactions. The CMC Director will lead the Global Regulatory Affairs CMC gene therapy team, reporting to the Vice President of Regulatory Affairs. He/she will design, develop, and implement regulatory CMC strategy across all gene therapy projects; will deliver regulatory strategy objectives across all teams/projects, including operational risk management; and will work collaboratively across functions and teams to develop and implement regulatory CMC strategies. The CMC Director will be proactive with a “roll-up sleeves” mindset.  The CMC Lead will develop and maintain active relationships with all CMC/manufacturing personnel across all projects and provide feedback to the Vice President of Regulatory Affairs.

The CMC Lead will also develop relationships with health authorities and lead the preparation of health authority interactions in the area of CMC; provide CMC regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent; evaluate current processes and communication links and assess opportunities for improvement. Experience in working with and influencing partners (CROs, CDMOs) in a collaborative development setting would be advantageous. The CMC Lead will be recognized internally and externally as an expert in gene therapy regulations, guidelines and precedents related to pharmaceutical development.

Key Responsibilities 

  •  Lead the Global Regulatory Affairs CMC gene therapy team, reporting to the Vice President of Regulatory Affairs
  • Ability to provide CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for gene therapy products; Design, develop, and implement regulatory CMC strategy across all gene therapy projects
  • Track record of identifying and communicating CMC regulatory risk areas and developing alternative courses of action
  • Maintain relationships with external regulatory professionals including CMC health authorities
  • Proven ability to actively collaborate with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners and CROs) to develop and execute robust CMC regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
  • Extensive experience planning, preparing, managing, and reviewing regulatory submissions including INDs, CTAs/IMPDs, briefing documents, responses to queries
  • Demonstrated leadership ensuring that regulatory submissions meet standards, quality, and guidance
  • Provide regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent
  • Define, manage and coordinate CMC regulatory workflow and budget for consultants and vendors
  • Track record of leading interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments)
  • Evaluate current processes and communication links and assess opportunities for improvement
  • Ability to remain current on CMC regulatory intelligence including guidelines, compendial requirements, and regulatory trends, and to drive and implement strategic policy decisions
  • Initiate and contribute to development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives
  • Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences including executive leadership

Qualifications

  • Advanced degree in a scientific discipline with 10+ years of pharmaceutical/biotechnology industry experience
  • Minimum of 8 years of experience working in regulatory affairs CMC, with some of this experience with gene therapy products specifically or significant complex biologics experience
  • Proficiency in regulatory environments including FDA, EMA and ICH
  • Experience in the preparation and successful submissions of CMC (Module 2 and Module 3, Fast Track, Prime Designations) regulatory submissions in key ICH regions (e.g. US INDs, Canadian and EU CTAs, etc.)
  • Ability to represent regulatory affairs group in project teams, committees, and external meetings, as well as with partners and collaborators related to gene therapy manufacturing and all aspects of CMC
  • Must be pro-active with a “roll up sleeves” personality
  • Experience in leading CMC submission preparation and Health Authority interactions
  • Strategic thinking and strong problem-solving skills
  • Strong interpersonal skills and the ability to communicate effectively cross-functionally
  • Strong oral and written communication skills
  • Solid knowledge and understanding of CMC and GMP related issues
  • Strong sense of planning and prioritization, and the ability to work with all levels of management in a matrix environment
  • Proven ability to work with interdisciplinary teams and dealing with unfamiliar situations
  • Strong leadership and project management skills, including demonstrated cross-functional communication, negotiation and conflict management skills
  • Travel: Some travel may be expected, as necessary, for meetings and to assess manufacturing sites