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.