Vice- President, Global Regulatory Affairs - NC Pharma

I am working on behalf of a North Carolina pharmaceutical firm to retain a top-notch candidate to become its Vice President of Global Regulatory Affairs.  My client is an established and expanding pharmaceutical firm whose R&D headquarters are in RTP.  The company has many marketed products and many more in development.  This is a world-wide operation that requires a seasoned and astute global perspective.  This is a growing organization that needs “a builder.”

 

The Vice-President will drive all world-wide Regulatory Affairs functions including strategy, compliance and submissions.  Seek top-notch candidate whose expert knowledge of world-wide Regulatory requirements, guidelines, practices and strategies are complemented by strong operational, logistical, communicative and business savvy.  Further, seek a natural leader who motivates outstanding personnel to deliver outstanding results.  Company wants a world-class operation here.  Need an accomplished and impactful leader to make it happen.

 

Ideal candidate…….

·  Advanced degree (doctorate preferred) with 10+ years in increasingly responsible roles within the pharmaceutical Regulatory Affairs function

·  Extensive bkgd building and driving Global Regulatory Affairs teams

·  Demonstrated thorough knowledge of most of the critical functions within regulatory affairs.  Experience with promotional material review, CMC regulatory, labeling, generics and regulatory operations all highly desired

·  Demonstrated ability to develop quality and productive relationships with key external and internal constituencies.  Persuasive and effective communicative skills expected

·  Substantial experience in a leadership role in filings of INDs, NDAs, ANDAs, BLAs, 510(k)s preferably in CTD format or eCTD format and in many regions of the world

·  Outstanding negotiation skills

 

Client will pay absolute top dollar to attract and retain outstanding candidate.  Please forward Word resume to leef@frankelstaffing.com .