Regulatory Project Manager Job At GSK
GSK is hiring a Regulatory Project Manager to lead CMC regulatory activities for the Vaccines portfolio across multiple global locations. This full-time Manager Job role focuses on regulatory strategy, dossier preparation, lifecycle management, and cross-functional collaboration to support global market authorizations and regulatory compliance. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
Job Details
- Job Title: Regulatory Project Manager
- Location: Bengaluru, India; Worli Mumbai, India; Cairo, Egypt; Poznan, Poland; Warsaw, Poland
About the Company
GSK is a global biopharmaceutical company with a mission to unite science, technology, and talent to get ahead of disease together. With a focus on vaccines and specialty medicines, GSK aims to positively impact the health of 2.5 billion people by the end of the decade. The company fosters a culture that is ambitious for patients, accountable for impact, and committed to doing the right thing. This Manager Job role plays a significant role in the company.
Educational Requirements
-
PhD or Master’s degree in Pharmacy
Key Responsibilities
- Drive CMC regulatory strategy for vaccines and pharmaceutical products
- Coordinate and author complex CMC regulatory dossiers for marketing authorization and lifecycle activities
- Identify and manage regulatory risks related to submission data packages
- Lead CMC regulatory discussions with worldwide regulatory authorities
- Review and approve technical dossiers as Subject Matter Expert and Technical Dossier Approver
- Contribute to creation, maintenance, and continuous improvement of CMC regulatory processes and systems
- Ensure effective collaboration with Global Regulatory Leads, Quality, Supply Chain, QA, and local operating companies
- Mentor and train team members, developing CMC regulatory subject matter expertise
- Provide regulatory support to in-licensing, divestment, and R&D projects
- Represent GSK during audits, regulatory interactions, and external forums when required
Skills Required
- Strong expertise in global CMC regulatory requirements
- Experience with vaccines and/or biologics regulatory submissions
- In-depth understanding of pharmaceutical development, manufacturing, and supply processes
- Proven project management and multi-tasking capabilities
- Ability to manage matrix teams and multiple global projects
- Strong communication, influencing, and stakeholder management skills
- Risk assessment and problem-solving abilities in complex regulatory environments
Why This Job Role?
This Manager Job role offers high visibility and strategic impact within a global biopharma organization. You will work on complex global CMC submissions, collaborate with senior stakeholders, and contribute directly to vaccines that improve global health – while benefiting from strong career development, flexibility, and competitive rewards. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.