Regulatory Lead

Proclinical is currently recruiting for a Regulatory Lead with a biotechnology company located in San Francisco, CA.

Job Responsibilities:

• 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.

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