CMC Regulatory Project Manager

Job Description 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 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. 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. At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together. 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. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [Confidential Information] 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. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive Important notice to Employment businesses/ Agencies 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 GSK's 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 such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional 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/