Regulatory Lead job in Philadelphia, USA

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Job type: Permanent

Discipline: Project Manager, Publishing & Submissions, RA Intelligence

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Regulatory Lead with a biotechnology company located in Philadelphia, PA.

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.

#LI-ZH1

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