Current Openings

Senior Manager Regulatory Operations

New York, NY

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.

Position Summary:

The Senior Manager of Regulatory Operations will be responsible for managing the regulatory operations infrastructure and overseeing the regulatory publishing and document management needs of MeiraGTx.   This includes, but is not limited to, document archiving, submission planning, publishing, QC, and electronic submissions through the US FDA and other Health Authority portals worldwide.

This position reports to the VP of Regulatory Affairs.  It is a hands-on role.  In time, the addition of responsibility for managing personnel is anticipated. The successful candidate must have significant experience handling all types of regulatory submissions from early phase through post-approval.  Significant experience with eTMF and Veeva Vault is strongly preferred.

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