New York, New York
about 1 month ago
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.
- 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
- 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 firstname.lastname@example.org if you are interested in working with a leading organization in the industry.