GSK Careers: Regulatory Project Manager Jobs | Apply Now

GSK Careers: Regulatory Project Manager Jobs | Apply Now

Are you looking for Project Manager roles in global pharma regulatory affairs? GSK Careers presents an excellent opportunity for experienced professionals seeking Regulatory Project Manager jobs across India, Poland, and Egypt. This role is well-suited for candidates from science backgrounds, including those exploring MSc Chemistry jobs with strong exposure to vaccines and pharmaceutical regulatory strategy.

About GSK

GSK (GlaxoSmithKline) is a world-leading biopharmaceutical company focused on uniting science, technology, and talent to get ahead of disease together. Through GSK Careers, the company offers rewarding opportunities for professionals seeking Project Manager jobs, advanced MSc Chemistry jobs, and leadership roles in global regulatory and R&D functions.

  • Job Title: Regulatory Project Manager
  • Job ID: 433514
  • Locations: Bengaluru, India; Worli, Mumbai, India

Position Summary

The Regulatory Project Manager will lead regulatory projects for the Vaccines portfolio that support product lifecycle activities across markets. Working closely with regulatory affairs, clinical, quality, supply, and external partners, this Project Manager role offers visible impact, professional growth, and alignment with GSK Careers’ mission of uniting science, technology, and talent to get ahead of disease together.

Key Responsibilities

  • Drive strategy for CMC regulatory submissions
  • Coordinate and author complex CMC technical regulatory dossiers
  • Support marketing authorisation, lifecycle activities, and maintenance of registered products
  • Identify regulatory risks and lead CMC discussions with worldwide regulatory authorities
  • Contribute to the creation and continuous improvement of CMC regulatory processes
  • Serve as mentor, Subject Matter Expert, and Technical Dossier Approver
  • Partner with global regulatory, quality, supply chain, and leadership teams

Basic Qualification

  • Proven experience in independently managing global CMC regulatory strategies
  • Strong understanding of internal and external regulatory environments
  • Ability to author regulatory responses and interact with worldwide regulatory authorities
  • Experience supporting R&D, Quality Control, GSC, QA, and LOC teams
  • Strong project management, risk assessment, and stakeholder management skills

Requirements

  • PhD/Master’s degree or above in Pharmacy, Biotechnology, Biology, Chemistry, or a closely related science.
  • Experience in Vaccines/Biologics.
  • Sound knowledge and understanding of drug development and manufacturing, and supply processes, and may have a specialized area of expertise.
  • Demonstrated ability to handle complex global CMC submissions and issues through continuous change and improvement.
  • Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
  • Proven project management and multi-tasking skills.
  • High ability to manage matrix teams and direct multiple projects.
  • Experience in influencing and negotiating with GSK personnel in a variety of settings.

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