CMC Regulatory Project Manager

Role Summary

CMC Regulatory Project Manager at GSK within Global Regulatory Affairs, focused on shaping regulatory strategies for lifecycle management of marketed small molecules, ensuring uninterrupted access to medicines and aligning with sustainability goals. Collaboration across Global Supply Chain, Technical, Quality, and Local Operating Companies to support regulatory submissions and product control.

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 working closely 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

• Required: Bachelor’s degree (or equivalent) in pharmacy, chemistry, or a related scientific discipline.
• Required: Proven experience in CMC regulatory affairs or product development, including preparation of regulatory submissions for late-phase development and/or marketed product lifecycle management.
• Required: Strong understanding of drug development, manufacturing processes, and supply chain.
• Required: Knowledge of global CMC regulatory requirements, with a track record of delivering complex regulatory strategies and overseeing submission writing.
• Required: Excellent time management skills and the ability to prioritize multiple tasks in a fast-paced environment.
• Preferred: Master’s or Ph.D. degree (or equivalent) in pharmacy, chemistry, or a related scientific discipline.
• Preferred: Regulatory Affairs Certification (RAPS) or equivalent professional certification.
• Preferred: Demonstrated expertise in influencing and negotiating with internal teams and regulatory agencies.
• Preferred: Experience implementing regulatory strategies that impact global projects and product plans.
• Preferred: Strong interpersonal, presentation, and communication skills, with a proactive approach to process improvement.
• Preferred: Recognized as a CMC Regulatory expert in a specific subject area, with the ability to lead through continuous change and improvement.