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CMC Regulatory Specialist

1 tydzień temu

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GRC Regulatory Affairs Professional

The Renewals CMC Team within the Global Regulatory Centres (GRC) is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control. We are seeking a highly skilled Regulatory Specialist with expertise in Chemistry, Manufacturing, and Controls (CMC).

Key Responsibilities:

  • Evaluate and implement innovative solutions for CMC regulatory processes, policies, and systems.
  • Manage multiple CMC renewals assignments for pharmaceutical and vaccines products, including response to questions from regulatory agencies.
  • Collaborate with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies worldwide to deliver high-quality dossiers on time.
  • Act as subject matter expert in regulatory processes and monitor regulatory intelligence.

Job Requirements

  • Relevant degree or equivalent experience in regulatory affairs, chemistry, or a related field.
  • Proven track record in managing CMC regulatory submissions and responding to agency queries.
  • Excellent communication and collaboration skills.

Benefits

We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.