CMC Regulatory Project Manager

Role Summary

CMC Regulatory Project Manager at GSK, within the CMC Regulatory Affairs group of Global Regulatory Affairs. Role involves shaping regulatory strategies for lifecycle management of marketed small molecules, supporting cross-functional collaboration, and driving regulatory initiatives aligned with corporate goals.

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 minimize 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’s 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.
• 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 (Preferred).

Skills

• Regulatory strategy development
• Cross-functional collaboration
• Lifecycle management submissions
• Regulatory guidance and compliance
• Submission writing and management

Education

• Bachelor’s degree in pharmacy, chemistry, or related scientific discipline (required); Master’s/PhD and regulatory certification (preferred).

Additional Requirements

• Hybrid working model; willingness to collaborate across global sites as needed.