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Associate Director Regulatory Affairs Generics

HIRING: Associate Director, Regulatory Affairs - Generics - Leading Global Pharmaceutical - New Jersey
Hays Life Sciences is currently partnered with a leading global pharmaceutical company to assist them in their search for an Associate Director, Regulatory Affairs – Generics to be based in New Jersey. This company boasts an impressive portfolio of branded pharmaceutical drugs, generic products, OTC medication, medical devices, and cosmetics. The Associate Director, Regulatory Affairs – Generics will be a valuable addition to the Regulatory Affairs team.

In this capacity, you will be responsible for developing a product regulatory strategy for complex generic pharmaceutical products. You will develop regulatory timelines, coordinate with the Labeling Lead on the development and maintenance of product labels, ensure timely submissions to health authorities and serve as a primary regulatory contact with health authorities for assigned generic products. In addition, you will keep the business informed of FDA policies and intelligence for generic drugs.

At minimum, you must possess a Bachelor’s degree in a scientific discipline, 10+ years of Regulatory Affairs pharmaceutical industry experience, complex generics experience (non-solid oral dosage products), and experience with bioequivalence studies with clinical endpoints. Biosimilars experience is a bonus.

Apply now for consideration.

Summary

Job type:
Full Time
Industry
Pharmaceuticals
Location
New Jersey
Specialism
Pharma
Pay
Competitive / Based on Experience
Ref:
1105054
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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