Proclinical is currently recruiting for a Regulatory Lead with a biotechnology company located in Durham, NC.
- 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:
- Regulatory Strategy Experience.
- Experience leading submission teams with (IND, BLA, NDA).
- 5-7 years of U.S Relevant Regulatory Experience.
- Neurology, immunology experience a plus.
- Leadership 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.