Director, Regulatory Affairs
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Location
New York, New York
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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:
2020-11-20
Hamlyn Williams has partnered with an exciting Pharmaceutical and Medical Device company in their search for a Director of Regulatory Affairs. Our client seeks a candidate who will support a variety of regulatory projects from development through post-approval. This client is publically traded and located in New York City.
Job Description:
- You will be responsible for the implementation of regulatory strategies for medical device products and ensuring those activities maintain consistency within said regulatory strategy
- Regulatory project management and oversight of documentation for both new and ongoing global clinical oncology trials
- Ensure regulatory continuous compliance with FDA
- Prepare, review and submit domestic and international regulatory submissions including: NDA, IND and CTA
- Responsible for IND reports as well as annual and supplemental reports to the FDA for both INDs and NDAs
- Review programs and provide Regulatory Affairs SOPs
- Resolve any regulatory compliance issues
Qualifications:
- A BS or MS in life or physical sciences is required. An MBA, additionally, is a plus.
- 7-10+ years of regulatory affairs oncology experience in the pharmaceutical industry
- Direct experience within Regulatory Affairs clinical trial conduct
Apply here or email a.mckenna@hamlynwilliams.com if you are interested in working with a leading organization in the industry.