Join to apply for the CMC Regulatory Project Manager role at GSK

Site Name: UK – London – New Oxford Street, Bengaluru Luxor North Tower, Egypt - Cairo, Poznan Grunwaldzka, USA - North Carolina - Durham, Warsaw

Posted Date: Oct 27 2025

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 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:

• 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.

Closing Date for Applications: 10th November 2025 (EOD)

Please note GSK is an Equal Opportunity Employer. This ensures all qualified applicants 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, military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all roles. If flexibility is important to you, please discuss opportunities with our hiring team.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us on UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available 8:30am to 12:00 noon Monday to Friday. If your enquiry does not relate to adjustments, please refer to our UK Recruitment FAQ guide.

Important notice to Employment businesses/ Agencies: GSK does not accept referrals from employment businesses and/or employment agencies for vacancies posted on this site. Prior written authorization is required before referring candidates. This is a condition precedent to any agreement between the employment business/agency and GSK.

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 people by the end of the decade, focusing on vaccines and medicines across four therapeutic areas: respiratory, immunology and inflammation, oncology, HIV, and infectious diseases. We are committed to creating an environment where our people can thrive and focus on what matters most. Our culture is ambiti ous for patients, accountable for impact and doing the right thing.

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, sexual orientation, gender identity, national origin, age, disability, genetic information, military service, or any basis prohibited under applicable law.

Note: The description below includes legal and process details and should be used for reference when applying.