Project Manager Job at GSK: Regulatory CMC Role | Apply Now
GSK is offering an exciting project manager job opportunity for professionals experienced in Regulatory and CMC functions within the pharmaceutical industry. This role supports global vaccine development through complex regulatory submissions while collaborating with cross-functional teams worldwide. As part of GSK careers, this position allows professionals to contribute to life-saving medical innovations, making it a highly impactful role in today’s growing medical jobs landscape.
Job Details:
- Position: Regulatory Project Manager (Delivery Lead)
- Job ID: 433514
- Location: Bengaluru, Worli, Mumbai. Cairo, Egypt, Poznan Grunwaldzka, Poland, Warsaw, Poland
About the Company:
GSK is a global biopharma company focused on uniting science, technology, and talent to get ahead of disease together. Through innovation in vaccines and specialty medicines, GSK aims to positively impact the health of 2.5 billion people by the end of the decade. Opportunities within GSK careers allow professionals to thrive while contributing to meaningful advancements in healthcare and medical jobs worldwide.
Job Description:
At GSK, continuous development of new products and improvement of established medicines is essential to improving human health. This project manager job plays a key role in ensuring that all changes for Finished Products and Drug Substances are properly registered and maintained. GSK is currently seeking a Regulatory Project Manager (Delivery Lead) to join the GRA Vx Mature CMC team. This role supports impactful initiatives, operational efficiency, and innovation, contributing directly to the delivery of life-saving vaccines within the global medical jobs ecosystem.
Qualifications:
- Master’s degree or higher in medical or related fields
- Strong experience in CMC Regulatory Affairs within pharmaceutical or research organizations
- Expertise in CTD Module 1–3 dossier preparation and regulatory strategy
- Knowledge of regulatory processes, ICH guidelines, and EU frameworks
- Strong analytical, communication, and organizational skills essential for senior medical jobs
- Excellent English writing and documentation skills
Key Responsibilities:
- Take ownership of multiple complex CMC regulatory submissions, including planning, coordination, and execution
- Manage CMC variations and Health Authority Questions for vaccines, APIs, and intermediates
- Identify risks related to submission data and support mitigation strategies
- Collaborate with Global Regulatory teams, Supply Chain, Quality Assurance, LOCs, and third parties
- Drive improvements in CMC regulatory processes and systems
- Serve as Subject Matter Expert while mentoring and guiding team members in this project manager job
