US Regulatory Lead
Proclinical is currently recruiting for a US Regulatory Lead with a biotechnology company located in Cambridge, MA.
- Responsible for all aspects of the US Regulatory Strategy for assigned development and marketed products.
- Critical member of the Regulatory Product Team (RPT) providing US focused product strategy, US regulatory framework knowledge, and awareness of external regulatory initiatives.
- Serves as the single point of contact for R&D and the US business on regulatory issues for development and marketed products.
- Partners with the Global Regulatory Lead (GRL) and will participate on cross-functional project teams representing Regulatory on an agenda driven basis.
- Present the US regulatory position on assigned products to senior management governance committees as needed.
Skills and Requirements:
- 5+ years of regulatory experience
- Experience with regulatory strategy
- Experience with FDA guidelines
- Experience in pharmaceutical industry
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.