Regulatory Affairs Specialist

3 weeks ago


Durham, North Carolina, United States GSK Full time
About the Role

We are seeking a highly motivated Regulatory Affairs professional to join our CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Group. As a Regulatory Project Manager (CMC), you will be responsible for providing CMC support to a defined portfolio of marketed drug substances and products for global markets.

Key Responsibilities
  • Develop and implement CMC strategies for CMC submission documents to support small molecule marketed product lifecycle management activities.
  • Ensure all appropriate CMC regulatory aspects for product release are in place to ensure continuity of market supply.
  • Work in cross-functional matrix project teams to define proper regulatory CMC filing strategy.
  • Maintain high quality standards and ensure regulatory compliance is maintained.
About You

This role requires a driven and motivated individual with experience of working in a complex Regulatory environment. You will have excellent people skills and be able to work across boundaries, responding readily to changing events and priorities.

You will need to be open-minded, with excellent communication skills and have proven experience dealing with diverse stakeholder groups. You should be comfortable dealing with issues which may initially appear ambiguous or unclear and demonstrate an ability and willingness to help resolve complex problems as they arise.

Basic Qualifications
  • Bachelor's degree or equivalent within a relevant subject such as pharmacy, chemistry, or a related scientific discipline.
  • CMC regulatory affairs or product development experience.
  • Direct involvement in regulatory submission preparation in late phase development and/or marketed product life cycle submissions.
Preferred Qualifications
  • Master's degree within a relevant subject such as pharmacy, chemistry, or a related scientific discipline.
  • Regulatory Affairs Certification (RAPS).
  • Continued professional growth in global regulatory affairs.


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