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 Associate, CSV

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

Provide QA oversight and support the implementation, development and management of compliance related electronic systems in accordance with EU/Annex 11, GAMP and FDA/21 CFR part 11 and Data Integrity GxP requirements (specifically GCP, GLP and GMP).

Perform general administration and maintenance activities required to support implemented systems.

Support Computer System Validation activities for GxP systems.

Major Activities

  • Support computer systems projects led by the QA Specialist, IT & CSV, including but not limited to:
    • Establishing system design requirements
    • Executing test scripts
    • Summarising validation activities
    • Defining supporting procedures
    • Liaising with business functions.
  • Develop and deliver robust training programmes for system users
  • Maintain user access for each system, including setting up new users and deactivating leavers, where required
  • Provide technical support to the business when using implemented systems
  • Maintain an excellent working relationship with internal IT department and troubleshoot system issues
  • Raise system-related quality events and support investigations
  • Identify and investigate potential system changes and support system-related Change Controls
  • Maintain excellent working relationships with system suppliers and escalate system issues
  • Author and update procedures and validation documentation relating to CSV
  • Support computer system validation & re-validation activities, including risk assessments
  • Support periodic system reviews for implemented systems and provide metrics for system performance
  • Ensure own training is undertaken in a timely and compliant manner before the task is undertaken
  • Ensure own KPI’s, plans, targets and objectives are effectively monitored and achieved
  • Stay up to date with best practice, regulatory intelligence and share knowledge

Key Performance Indicators

  • General maintenance of GxP systems is performed in a timely manner
  • GxP systems are maintained in a validated state throughout deployment and upgrades
  • GxP system users are appropriately trained on implemented systems
  • Internal technical support calls for GxP system are handled in a timely manner and escalated appropriately

Key Job Competencies

  • Maintain GxP systems in compliance with EU, GAMP and FDA GxP requirements
  • Execute activities related to Computer Systems Validation
  • Excellent communicator with the ability to deliver technical information to non-technical personnel with varying IT competencies
  • Approachable and professional manner
  • Effective written communicator, able to deliver concise documentation, adapting writing style to audience as appropriate
  • Effectively manage changes in accordance with Change Control processes

Job Background

  • Educated to degree level in Human Health, Sciences or equivalent
  • Minimum of 3 years experience working in a GxP environment with focus on IT compliance and CSV
  • IT literate with experience maintaining GxP IT systems
  • Knowledge of GxP regulations and guidelines relating to computer systems
  • English language required

QA Associate, Validation and Tech Transfer

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 role is required provide QA support for the manufacture and supply of Advanced Therapies Medicinal Products (Gene Therapy viral vectors).

The role will provide QA support for all validation and qualification activities across the Manufacturing facility and Laboratories at MeiraGTx. To ensure processes, analytical methods and equipment are appropriately validated and qualified in accordance with EU and FDA regulations and MeiraGTx policies.

Major Activities

  • Interface with other departments such as Engineering, QC, Operations, Warehouse and MSAT (Process Development) to ensure that validation project plans are understood and in keeping with site objectives.
  • Review and approve tech transfer, validation, qualification protocols and reports.
  • Deputise for line manager as directed.
  • Maintain understanding of cGMP, Good engineering practices and guidance in relation to all aspects of validation across manufacturing, analytical laboratories and facilities.
  • Support the generation of Process Validation, Analytical Method Validation and 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 Specialist, Validation & Tech Transfer, 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.
  • Maintenance and archiving of Validation documentation.
  • Support Regulatory Inspections and third party audits.

Key Performance Indicators

  • To support the implementation “best practice” in validation for a new GMP Gene Therapy manufacturing facility ensuring validation of the processes, analytical methods and equipment meets regulatory requirements.
  • To effectively implement 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.
  • Review the Quality Assurance of aseptic processing and capabilities, ensuring aseptic qualification of staff and the manufacturing facility meeting GMP requirements.
  • All responsibilities are performed in a timely manner, escalating any and all issues to senior management as and when they occur.
  • 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 Tech Transfer and 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.

Job Background Education

  • BSc in Science / Engineering

Languages – English

Experience

  • The successful candidate must have experience in GMP manufacture of parenteral products, with an emphasis on aseptic manufacturing.
  • Experience of GMP manufacturing requirements, the validation of facilities, processes, equipment and analytical methods.
  • Experience in using risk assessment tools including FMEA
  • Ability to balance needs of the business with the needs of the Regulatory challenges