Regulatory Affairs (CRO) - Mid to Senior Level Manager

Our client, an expanding RTP/Durham CRO, is actively recruiting for a top-notch Regulatory professional for a key role within its growing group. The select candidate will serve as the company-wide point-person for company wide Regulatory Affairs, amongst other things.  A 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:

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

Ensuring documents are both persuasive and compliant

Compiling CMC sNDA?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 CRO / pharmaceutical setting.  In addition, company will require broad & deep knowledge of regulatory 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