Regulatory Affairs Manager
Company: Job Juncture
Posted on: September 24, 2022
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.
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
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.
Bachelor’s Degree required
5- 8 years regulatory experience (CMC, Labeling and Clinical)
Regulatory Affairs Professional Society (RAPS) Certification
Keywords: Job Juncture, Trenton , Regulatory Affairs Manager, Executive , Cranbury, New Jersey
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