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  • Rockville, MD
  • Kyle Weber

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Associate Director/Director, Regulatory Affairs - CMC

ProClinical • Rockville, MD

Posted 2 months ago

Job Snapshot

Highly Competitive Salary

Job Description

ProClinical, in support of our client, are seeking an individual to fill the role of Associate Director, Regulatory Affairs, CMC, based in Maryland.


  • Manage the preparation of CMC submissions to the FDA with high quality and expedited fashion in collaboration with China CMC team and external vendors.
  • Seek expert advice and technical support as required for strategies and submissions including new applications and amendments, renewals annual reports, supplements and variations.
  • Develop strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of briefing documents.
  • Develop and communicate the regulatory CMC strategy and identify key issues throughout the project.
  • Manage products and change control in compliance with regulations and company policies and procedures.
  • Act as company CMC regulatory expert on project meetings with partners.
  • Study FDA regulation and guidance and prepare regulatory analysis report.
  • Provide CMC regulatory due diligence into business opportunities as needed.

Skills and Qualifications

  • BA or higher in related scientific field.
  • Working experience as CMC Regulatory of biologics required.
  • Prior experience of working with global clinical trials strongly preferred.

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 Kyle Weber at (+1) 646-367-2618 or upload your resume on our website -

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.


Job ID: RA.KW.22992
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