7 months ago
My client; clinical-stage biotech specializing in the neurological space are looking for a Senior Director of Regulatory Affairs to lead the RA department as they near IND filing. This position will report directly to the Chief Medical officer and have oversight of the RA department facilitating the teams growth and the business regulatory pathways.
- Build regulatory affairs department across product lifecycle; clinical development, CMC, labeling, Ad promo & commercial regulatory.
- Partner cross functionally with Clinical Development, medical and C-Suite to devise and roll out regulatory strategy to regulatory approval.
- Liaise/ interface as main POC to FDA and other international health bodies.
- Act as Regulatory SME meeting with board, investors and key internal/ external stakeholders.
- File IND in the short term.
- Develop Regulatory pathways as companies assets move through lifecycle.
- Advanced degree ; Ph.D , M.D, PharmD , MS
- 15+ years’ experience in Regulatory Affairs including direct interaction with FDA and other international regulators.
- Deep and demonstrable knowledge of the Biopharmaceutical industry specifically regulatory affairs.
- Knowledge and experience within regulatory affairs across the product including; development , CMC, Labeling, Advertising & Promotion and Commercialization.
- Experience in leading / managing cross-functional teams .
- Experience interacting at board level and managing internal/ external key stakeholder relationships.
If of interest please apply with a fully updated CV encompassing any of the above points you see fit in either a cover letter and/ or email. email@example.com