Job Title

CMC Regulatory Project Manager

Company

GSK

Location

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

Posting Dates

Posted: Oct 27 2025

Closing Date: 10th November 2025 (EOD)

Overview

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.

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.

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.

Benefits

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.

Application Information

Please use the ‘cover letter’ and 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. When applying for this role, please take a copy of the Job Description, as this will not be available post closure of the advert.

Equal Opportunity Statement

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.

Adjustments

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

Agency Information

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from any actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Compliance and Reporting

For US Licensed Healthcare Professionals or Healthcare Professionals as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/