Senior Director, Regulatory Affairs-Bedminster NJ


My client is a Public Biopharma focused on Rare Disease  in Infectious and Pulmonary Diseases-Bedminster NJ

You will lead the development of regulatory strategy and manage all regulatory submissions and interactions for this Public company.

You will also— provide guidance on both internal and external regulatory activities- NDs, IMPDs, MAAs, NDAs

You will develop long term strategies and execute short term goals for regulatory, clinical and CMC, in alignment with the company’s commercial goals.

 

Job Requirements:

 

Advanced degree preferred.

10+ years regulatory affairs experience in a pharmaceutical or biotech company, including senior management experience.

Must have a proven track record with IND’d/NDA’s (that were successful)

Experience with Rare Disease drugs  is desired

Direct interaction experience with FDA required.

Thorough knowledge and practical application of domestic and international regulations including cGMPs, GLP, GCP and ICH.

 

Please send your resume as an attached WORD doc in confidence directly to mike@coastalsa.com

 

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