Regulatory Lead

Highly Competitive Salary
  1. Permanent
  2. Project Manager, Publishing & Submissions, RA Intelligence
  3. United States
Durham, USA
Posting date: 01 Oct 2020
RA.ZH.33285

Proclinical is currently recruiting for a 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:

  • 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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