Associate Director, Regulatory Affairs
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Location
New Jersey
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Sector:
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Contact:
Adele McKenna
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Contact email:
a.mckenna@hamlynwilliams.com
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Salary high:
0
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Salary low:
0
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Published:
4 months ago
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Expiry date:
2020-12-12
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Startdate:
Immediate
Hamlyn Williams has partnered with an exciting Pharmaceutical company, based in New Jersey, in their search for an Associate Director of Regulatory Affairs. Our client seeks a candidate who will support a variety of regulatory projects, primarily focused in novel therapies in the oncology space.
Job Description:
- You will be responsible for managing CMC development and post marketing
- Responsible for developing and executing strategy and submissions
- Leading health authority interactions for both the US and EU interactions
Qualifications:
- A MS/PhD degree in a related scientific discipline
- 8+ years of pharmaceutical industry experience
- 4+ years of CMC experience
- Experience with preperation, management and review of filings such as: NDA, MAA and BLA with both the FDA and EMA
Apply here or email a.mckenna@hamlynwilliams.com if you are interested in working with a leading organization in the industry.