Site Name:
UK London New Oxford Street, Bengaluru Luxor North Tower, Egypt - Cairo, Poznan Grunwaldzka, USA - North Carolina - Durham, Warsaw
Posted Date:
Oct 27 2025Are you a driven and innovative Regulatory Affairs professional looking to make a meaningful impact on the global supply of medicinesJoin our Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Group within Global Regulatory Affairs at GSK, where we play an essential role in ensuring uninterrupted access to life-changing medicines for patients worldwide.As part of the CMC Regulatory Affairs team, you'll collaborate across Global Supply Chain (GSC), Technical, Quality, and Local Operating Companies to support lifecycle management of marketed small molecules. In this exciting role, you'll help shape regulatory strategies, drive sustainability initiatives that align with GSK's 2030 environmental goals, and deliver high-impact solutions that enhance the way we manufacture and control our medicines.To succeed in this role, you'll be a proactive, motivated individual with experience navigating complex regulatory environments. You will thrive in cross-functional settings, demonstrating excellent people skills and the ability to build strong relationships with diverse stakeholders. Your communication skills will be critical in resolving ambiguous or complex challenges, and your open-minded, adaptable approach will set you apart as a leader in regulatory strategy.We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.Discover more about our company wide benefits and life at GSK on our webpage
Life at GSK | GSK
In this role you will:
- 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.
Why you
Basic Qualifications & Skills:
We are looking for a professional with these required skills to achieve our goals:
- 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.
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- Master's or Ph.D. degree (or equivalent) in pharmacy, chemistry, or a related scientific discipline.
- Regulatory Affairs Certification (RAPS) or equivalent professional certification.
- Demonstrated expertise in influencing and negotiating with internal teams and regulatory agencies.
- Experience implementing regulatory strategies that impact global projects and product plans.
- Strong interpersonal, presentation, and communication skills, with a proactive approach to process improvement.
- Recognized as a CMC Regulatory expert in a specific subject area, with the ability to lead through continuous change and improvement.
At GSK, we're committed to improving the quality of human life by enabling people to do more, feel better, and live longer. As a CMC Regulatory Project Manager, you'll contribute to this mission while advancing your career in an environment that fosters collaboration, innovation, and professional growth.Join us to help shape the future of healthcare and make a difference in the lives of patients worldwide.
Closing Date for Applications: 10th November 2025 (EOD)
Please take a copy of the Job Description, as this will not be available post closure of the advert.
