CMC Regulatory Project Manager

Role Summary

CMC Regulatory Project Manager at GSK within Global Regulatory Affairs (CMC Regulatory Affairs Group). Collaborate across Global Supply Chain, Technical, Quality, and Local Operating Companies to support lifecycle management of marketed small molecules; shape regulatory strategies and drive sustainability initiatives aligned with 2030 environmental goals; deliver high-impact solutions to improve manufacture and control of medicines.

Responsibilities

• Develop and deliver regulatory strategies for global, regional, and local market submissions, ensuring compliance with evolving regulations and scientific standards.
• Provide expert guidance to multidisciplinary teams on regulatory requirements, policies, and guidelines related to the manufacture and control of medicinal products.
• Support lifecycle management submissions, ensuring alignment with regional requirements and minimizing questions from Health Authorities.
• Collaborate in cross-functional matrix teams with Regulatory, Development, Quality, Technical, and Manufacturing stakeholders to define effective regulatory filing strategies.
• Ensure continuity of market supply by managing regulatory aspects of product release.
• Drive innovation and continuous improvement to respond to the evolving regulatory environment.
• Share best practices and learnings across the CMC Regulatory teams and other impacted functions to enhance regulatory compliance and efficiency.

Qualifications

• Bachelor‚Äôs degree (or equivalent) in pharmacy, chemistry, or a related scientific discipline.
• Proven experience in CMC regulatory affairs or product development, including preparation of regulatory submissions for late-phase development and/or marketed product lifecycle management.
• Strong understanding of drug development, manufacturing processes, and supply chain.
• Knowledge of global CMC regulatory requirements, with a track record of delivering complex regulatory strategies and overseeing submission writing.
• Excellent time management skills and the ability to prioritize multiple tasks in a fast-paced environment.

Skills

• Regulatory strategy development for global/regional/local submissions
• Cross-functional collaboration and stakeholder management
• Lifecycle management and regulatory submission writing
• Regulatory compliance and continuous improvement
• Communication and negotiation with internal teams and regulatory agencies

Education

• Required: Bachelor‚Äôs degree in pharmacy, chemistry, or related field
• Preferred: Master‚Äôs or Ph.D. in related scientific discipline

Additional Requirements

• Regulatory Affairs Certification (RAPS) or equivalent certification (preferred)
• Ability to influence and negotiate with internal teams and regulatory agencies
• Experience implementing regulatory strategies affecting global projects and product plans
• Strong interpersonal and presentation skills; proactive process improvement mindset