Regulatory Affairs (Pharma) - Senior Manager (Top Dollar)

Our client, a Durham-based specialty pharmaceutical firm undergoing unprecedented growth, is actively recruiting for a top-notch Regulatory professional for key role within its R&D group. Incumbent will serve as the company-wide point-person for all Regulatory submissions, amongst other things.  High-level of competence and knowledge will be critical.Seek a proactive, communicative manager who anticipates and builds in quality/process such that, at the time of submission, the right things have already been done. 

Technical and experience requirements listed below must be complemented by a "roll-up-your sleeves, get the job done" work style. Environment is fast-paced and dynamic. Need a sharp overachiever who can make things happen.

Specific responsibilities will include:

  Driving the FDA submission process through work done by large project teams

  Ensuring documents are both persuasive and compliant

Providing regulatory input and strategy on for marketing, manufacturing, clinical, quality and other project teams

Compiling NDA?s and the CMC section of IND?s and NDA?s

Developing expanding knowledge base on marketed products and products in development

 

Selected candidate will offer advanced degree in related major and 8+ years of regulatory experience in a pharmaceutical setting.  In addition, company will require broad & deep knowledge of regulatory submission process(IND/NDA success), compliance management, strategic analysis & strong entrepreneurial instincts.

 

Industry-leading base will be complemented by outstanding benefits, bonus and stock packages.  Please forward Word resume.  Local candidates only