Regulatory Affairs Manager looking for a dynamic, fast-paced role

Regulatory Affairs Manager
 
As the Regulatory Affairs Manager, you will lead all corporate, regulatory functions in a smaller, pharmaceutical manufacturing organization.  The organization has some very aggressive growth plans that include a substantial volume of new products.  This role will be intimately involved with the full compliment of new product introduction functions and specifically, the direct responsibility for all NDA and ANDA submissions.  This role will also work extensively with the Labeling function. 

Requirements

Minimum Bachelor’s degree in a scientific discipline.  Advanced degree preferred.

Minimum 10 years experience in the pharmaceutical industry with an emphasis on Scientific and Regulatory affairs
Extensive working knowledge of ANDA preparation & documentation
Demonstrated experience in labeling requirements

Strong working relationship with the FDA is critical

Must have previous managerial level experience for consideration. 


Benefits
We offer fabulous potential for motivated professionals, great compensation, and full benefits including 401K, a cash bonus, relocation assistance, a stock option plan, dental insurance, medical insurance, and life insurance.  Pre-employment drug screening required. 

Your personal privacy and confidentiality are guaranteed.

Our firm is currently recruiting for several junior, mid, and senior level Quality, Regulatory and R & D positions throughout the US.  If your qualifications do not meet the specified requirements for this position; but, you do have Quality, Regulatory or Research & Development experience in pharmaceutical, food, beverage, biotechnology or CPG manufacturing, send a resume to the e-mail in connected to this posting and include a cover letter stating your career and relocation parameters