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Biotechnology Jobs at GSK
GSK is hiring a Regulatory Project Manager to lead CMC regulatory activities for its Vaccines portfolio across multiple global locations. This role plays a critical part in managing complex regulatory submissions, coordinating cross-functional teams, and ensuring compliance across product lifecycles. The Biotechnology Jobs at GSK are ideal for experienced regulatory professionals. This position offers high visibility, leadership responsibility, and meaningful impact on global public health.
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 bold ambition to positively impact the health of 2.5 billion people by the end of the decade, GSK focuses on innovation across vaccines and specialty medicines.
GSK’s R&D combines deep expertise in immunology with advanced technology to deliver high-impact therapies. The company fosters an inclusive culture where people are ambitious for patients, accountable for impact, and committed to doing the right thing.
Job Details:
- Job Title: Regulatory Project Manager
- Job ID: 433514
- Locations: Bengaluru and Worli, Mumbai, India
- Job Type: Full-Time
- Department: Regulatory Affairs
- Portfolio: Vaccines
Educational Requirements for the Regulatory Project Manager Role:
- PhD or Master’s degree in Biotechnology, Biology, or a closely related scientific discipline
Key Responsibilities:
- In this Regulatory Project Manager role, you have to lead the CMC regulatory strategy for vaccine products across the product lifecycle
- Coordinate and author complex CMC regulatory dossiers for marketing authorisation, lifecycle management, and product maintenance
- Drive risk identification and mitigation related to submission data and regulatory packages
- Lead and support CMC regulatory interactions with global health authorities
- Serve as Subject Matter Expert (SME) and Technical Dossier Approver
- Contribute to the creation, maintenance, and continuous improvement of CMC regulatory processes, policies, and systems in this Regulatory Project Manager role.
- Collaborate closely with Regulatory Affairs, Clinical, Quality, Supply Chain, QA, and external partners
- Author responds to regulatory agency questions and manages commitments
- Mentor and train new team members; support the development of internal SMEs
- Represent GSK externally in audits, conferences, and regulatory forums as required
Skills Required for the Biotechnology Jobs:
- Strong expertise in global CMC regulatory requirements for pharmaceuticals and vaccines
- Proven experience managing complex, multi-market regulatory submissions
- Deep understanding of drug development, manufacturing, and supply processes
- Excellent project management and multitasking capabilities
- Ability to manage matrix teams and senior stakeholders
- Strong risk assessment, problem-solving, and decision-making skills are required for the Biotechnology Jobs at GSK.
- High-level written and verbal communication skills for complex regulatory topics
- Ability to influence internal and external stakeholders across global environments
Preferred Qualifications:
- Experience in Vaccines and/or Biologics
- Demonstrated success in handling global CMC regulatory strategies
- Advanced knowledge of evolving worldwide regulatory frameworks
- Experience in influencing regulatory policy and negotiating with internal leadership
- Proven mentoring and leadership experience within regulatory teams
Salary & Benefits for the Biotechnology Jobs:
- Annual performance-based bonus (where applicable)
- Flexible working options
- Learning and career development programs
- Healthcare and well-being benefits
- Employee recognition programs
- Country-specific statutory and additional benefits (private healthcare, insurance, parental leave, pension plans, etc.)
Why Join GSK?
- Work on high-impact vaccines that protect global populations
- Be part of a company committed to ethics, inclusion, and patient-first innovation
- Grow your career in a globally connected regulatory leadership role
- Contribute directly to GSK’s mission of getting ahead of disease together.
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