QA 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

To provide Document Control support for the Irish manufacturing site during facility design, build and routine operations thereafter.

The Document Controller will work closely with the Irish project team and play a key role in providing hands on and “boots on the ground” support and control of documents generated as part of the project.

Major Activities

  • Establish and maintain a Document control system covering the document lifecycle from generation to obsoleting for documents generated as part of the project for documents controlled via eQMS, MasterControl or via a paper-based system
  • Provide Document Control support to the Irish project team ensuring that all documents generated are managed, maintained, stored and archived in compliance with EU, Irish and FDA cGMP regulatory requirements and MeiraGTx QMS Include 8-12 main activities
  • Setup a document management system for documentation generated and controlled outside MasterControl, ensuring documents are maintained in an easily retrievable state
  • Perform daily administrative tasks including, but not limited to:
    • Document Issuance, Review, Approval, Release, archiving and retention
    • Monitoring and tracking of document progression through lifecycle steps
    • Provide training within own area of responsibility
  • Author and maintain procedural documents related to management of documents within the QMS
  • Update and maintaining site training curriculum linked to procedures within the QMS
  • Provide Key Performance Indicator Reports for departments as required
  • Support the Quality Assurance team in issue and change control management where requested
  • Support the Quality Assurance team in other activities where requested
  • Support Customer Audit and Regulatory Inspections
  • Ensure own work complies with GMP, Data integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP’s
  • Ensure own training in undertaken in a timely and GMP compliant manner before the task is undertaken
  • Ensure own KPI’s, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines.
  • Can deputise for Document Controllers within the MeiraGTx network

Key Performance Indicators

  • Document control system is maintained in a compliant state
  • 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
  • Documentation maintained outside of the MasterControl system is maintained in a controlled but an easily retrievable state
  • Any records overdue are escalated appropriately to facilitate progression
  • Metrics Reports are accurate and provided in a contemporaneous manner as required

Key Job Competencies

  • Experience in working with electronic and paper based GMP 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
  • Experience and knowledge of working in a GMP regulated environment, specifically with regards to record retention

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

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