U.S. Regulatory Lead
Proclinical is currently recruiting for a U.S. Regulatory Lead with a biotechnology company located in Cambridge, MA.
- Core member of the RPT collaboratively working with the team to represent the US Business and weave US strategies into global strategies as they are developed.
- US participant on Product Cross Functional Team as appropriate.
- Key contact for FDA on product(s) and with direct FDA interaction. Ensures communications from FDA are properly communicated to the business after assessing the feedback and outlining next steps.
- Key contact for internal research, development and business partners on product(s).
- Drive US product labeling, working with the GRL to ensure core label changes are appropriately conveyed in US product labeling. Partners with US Commercial and Ad Promo Team.
- Responsible for IND, NDA, and BLA submissions to FDA in partners with Regulatory Operations.
- Responsible for product labeling, working with the GRL to ensure core label changes are appropriately conveyed in US product labeling.
- Regulatory representative on due diligence assessments of new business opportunities as required.
- Provide mentorship to junior regulatory staff.
Skills and Requirements:
- 8+ years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs.
- Delivery of at least one major application (NDA or BLA) or extensive experience with neurology late stage development/marketed products.
- Great leadership skills with high emotional intelligence.
- Must be a great team player with strong verbal and written communication skills.
If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.