Manager, Regulatory Affairs, CMC Vaccines

You will be responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of GSK products. Your key duties will include overseeing global CMC regulatory activities for assigned projects, developing CMC strategy for submission documents, ensuring regulatory compliance, and participating in cross-functional project teams to define proper regulatory CMC filing strategy. Additionally, you will be expected to maintain high-quality standards, seek continuous improvement, share best practices within the CMC Regulatory teams, and engage in CMC Subject Matter Expert activities. To excel in this role, you should have a minimum level of job-related experience in Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development with direct involvement in regulatory submission preparation. You should possess sound knowledge of drug development, manufacturing processes, and supply chain, along with expertise in worldwide CMC regulatory requirements. Strong time management skills, ability to prioritize tasks effectively, and adaptability to changing priorities are essential for success in this position. Preferred qualifications for this role include continued professional growth in global regulatory affairs, experience in influencing and negotiating with regulatory agencies, strong interpersonal and communication skills, and the ability to develop and implement regulatory strategies. Proven ability to handle global CMC issues, experience in major post-approval filing activities, and a proactive approach to process improvements are also desirable traits. GSK is a global biopharma company focused on uniting science, technology, and talent to prevent and treat disease. As an organization, GSK is committed to positively impacting the health of billions of people while delivering sustainable shareholder returns. By investing in core therapeutic areas and leveraging new technologies, GSK aims to make a difference in infectious diseases, HIV, respiratory/immunology, and oncology. If you are someone who is passionate about making a difference in healthcare, values continuous learning and growth, and thrives in a collaborative and innovative environment, GSK could be the perfect place for you to advance your career. Join us in our mission to get ahead of disease together and contribute to a healthier future for all. Please note that GSK does not accept referrals from employment businesses/agencies without prior authorization. If you receive unsolicited emails or job advertisements not ending in gsk.com, please disregard them and inform us at askus@gsk.com to verify the legitimacy of the job offer.,