about 2 months ago
July 1st (ASAP)
Hamlyn Williams Life Sciences is partnered with an exciting, clinical-stage biotech, looking to hire a Regulatory Affairs Lead with Global Regulatory experience (EU, Health Canada, and FDA preferred). The successful candidate will be based remotely, with the opportunity to travel once per month/quarter for key meetings.
- Participate as a critical thinking member of the Regulatory Affairs team to establish development and regulatory strategies for early-stage and late-stage development programs.
- Collaborate with cross-functional teams such as CMC, clinical, labeling, and post-approval, representing and coordinating regulatory information
- Liaise with EU, Canadian, and US Health Authorities
- Prepare IND, NDA, CTA, and BLA submissions including original marketing applications, amendments, supplements, variations, responses to Health Authority questions and requests, briefing packages, annual reports, periodic safety reports, etc.
- Participate in the electronic review and quality verification of regulatory submissions
- Ensure adherence to regulations and applicable guidelines for all regulatory submissions
- Provide risk assessments and recommendations for various regulatory scenarios
- Bachelor's degree required; Advanced degree preferred
- Minimum of 5-10 years of regulatory strategy experience within the pharmaceutical or biotechnology environment
- Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA/BLA stages
- Excellent verbal and written communication skills
- Ability to work with limited supervision, to set priorities to meet timeline