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Regulatory Affairs Manager

Company: Job Juncture
Location: Cranbury
Posted on: September 24, 2022

Job Description:

We're looking for a Regulatory Affairs Manager to join our client, a growing pharmaceutical company in Princeton, NJ!
The Regulatory Affairs Manager will implement and lead regulatory strategies and priorities while collaborating with CMC and Clinical/Project Management. They will be responsible for identifying and obtaining data needed and ensure effective presentation for submissions to Health Authorities. They will also manage the regulatory submission(s) and approval process. Additionally, the Regulatory Affairs manager will serve as point of contact with Health Authorities for routine communications in support of filings. 
Responsibilities



  • Responsible for the coordination and preparation of document packages for regulatory submissions to ensure the timely preparation of organized and scientifically valid submissions including INDs, IDEs, NDAs, BLAs and other FDA filings.


  • Reviews company and contractor activities relative to ICH guidelines, GCPs, GLPs, GMPs and other relevant regulatory guidance to ensure regulatory compliance


  • Keeps abreast of, evaluates impact, and analyzes trends of FDA regulatory developments.


  • Interacts with regulatory investigators, external consultants, manufacturers and consultants and the Company’s internal departments to ensure compliance and coordinate the successful execution of the Company’s regulatory affairs strategies.


    Requirements







    • Bachelor’s Degree required


    • 5- 8 years regulatory experience (CMC, Labeling and Clinical)


    • Regulatory Affairs Professional Society (RAPS) Certification preferred

Keywords: Job Juncture, Trenton , Regulatory Affairs Manager, Executive , Cranbury, New Jersey

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