Head of Regulatory Affairs

Where

Boston, MA

What you'll be doing

Lead regulatory strategy for neurology products (IND/NDA/CTA/MAA) in various stages of pipeline. Direct external agencies and internal management to define regulatory pathways. Act as the main contact for regulatory for company regarding senior management discussions and present issues. Get involved with development activities regarding the lead program. Create regulatory timelines and strategy for long-term planning at a cross functional level for product. Work with internal management to generate connections with various agencies. Manage internal regulatory affairs team, consultants, and vendors.

What your background should be

Minimum 12 years industry experience and 10 years regulatory leadership. Orphan designation and/or fast track approval experience is highly desired CNS/Neuroscience experience is required. Collaborative, high spirited, passionate, goal oriented, developed soft skills. Successfully filed NDA within pharmaceutical or biopharmaceutical.

Required Schooling / Training

BA/BS or MS or PhD in a scientific discipline preferred.

Who is the client company

This is one of the worlds largest and fastest growing international search firms and MRI network provider.

If you are interested in this position, send your resume to apply@kochdavis.com