Senior Manager of Regulatory Affairs
New York, NY
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.
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.
- 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
- 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