CMC Regulatory Project Manager

Are you a driven and innovative Regulatory Affairs professional looking to make a meaningful impact on the global supply of medicines?

Join 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 practices; 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:

• 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:

• 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.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

Find out more: Our approach to R&D

Why GSK? Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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