RA Lead CMC

Highly Competitive Salary
  1. Permanent
  2. CMC
  3. United States
District of Columbia
Posting date: 06 Jun 2019
RA.NW.23759_1559828472

ProClinical is currently seeking a Chemistry Manufacturing and Control Regulatory Affairs Lead for a biopharmaceutical company that develops high quality products for global markets.

Job Responsibilities

  • Develop and ensure integration of regulatory strategy in CMC activities.
  • Regulatory review of site supporting documents.
  • Change management, assessment regulatory part.
  • Represent RA in risk management activities.
  • Manage regulatory data base.
  • Lead project life cycle development stage from a regulatory perspective.
  • Leading interactions and responses to Health Authority questions.

Skills and Requirements

  • BS required.
  • 10+ years of regulatory management of CMC biologics experience required.
  • Knowledge of EU and US regulation.
  • Manufacturing, QA/QC experience or Health Authority experience.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nicholas Walker at (+1) 646-367-2908 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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#RegulatoryAffairs

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