CMC Regulatory Project Manager

Are 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 youll collaborate across Global Supply Chain (GSC) Technical Quality and Local Operating Companies to support lifecycle management of marketed small this exciting role youll help shape regulatory strategies drive sustainability initiatives that align with GSKs 2030 environmental goals and deliver high-impact solutions that enhance the way we manufacture and control our medicines.To succeed in this role youll 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 GSKIn this role you will:Develop and deliver regulatory strategiesfor global regional and local market submissions ensuring compliance with evolving regulations and scientific standards.Provide expert guidanceto 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 supplyby 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 youBasic Qualifications & Skills:We are looking for a professional with these required skills to achieve our goals:Bachelors 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:Masters 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 were 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 youll 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 peoples 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. Were uniting science technology and talent to get ahead of disease together.Find out more:Our approach to R&DWhy GSKUniting 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 were 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 or 0. 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 receiveImportant notice to Employment businesses/ AgenciesGSK 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 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 GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:IC Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type : Full-Time Experience: years Vacancy: 1