US Regulatory Lead

Highly Competitive Salary
  1. Permanent
  2. Officer /Associate, Project Manager, RA Intelligence
  3. United States
Durham, USA
Posting date: 20 Aug 2020
RA.ZH.31358A

Proclinical is currently recruiting for a US Regulatory Lead with a biotechnology company located in Durham, NC.

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:

  • 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.

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