Associate Director Regulatory Affairs CMC

HIRING: Associate Director, Regulatory Affairs CMC - Global Pharma - New Jersey
Hays Life Sciences is currently partnered with a leading global pharmaceutical company to assist in their search for an Associate Director, Regulatory Affairs CMC to be based in New Jersey. This company has a rich history of innovation and boasts a strong pipeline of clinical and commercial products across various therapeutic areas. The Regulatory Affairs CMC department has been growing rapidly at this organization. The Associate Director, Regulatory Affairs CMC will be an important addition to this expanding team.

In this capacity, you will develop regulatory CMC strategy, prepare content templates and lead technical teams in preparation of regulatory CMC submissions such as INDs, CTAs, IMPDs, IBs, NDAs, BLAs and MAAs. You will conduct regulatory risk assessments, liaise with health authorities, support health authority meetings and prepare briefing books. In addition, you will manage multiple CMC development and post-marketing projects, acting as a point of contact to cross-functional teams on US/EU RA CMC project issues.

At minimum, you must possess a Master’s degree (Ph.D. preferred) in a scientific discipline, 8+ years of pharmaceutical industry experience, 4+ years of direct Regulatory CMC experience, biologics experience and experience with IND and BLA submissions.

Apply now for consideration.


Job type:
Full Time
New Jersey
Competitive / Based on Experience
Apply Now

Talk to a consultant

Talk to Phu Huynh, the specialist consultant managing this position, located in New York City

16th Floor, 200 West 41st St

Telephone: 212 548 4525

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