Regulatory Affairs Specialist (Replacement of maternity leave, 2Y Contract)

Job description

JOB PURPOSE Lifecycle Management of Existing Products Plan, prepare, and submit regulatory variations for marketed products, including CMC changes, labeling updates, and maintenance of product licenses, ensuring ongoing regulatory compliance. Support for Regional and Global Regulatory Projects Manage and execute assigned regulatory projects and activities requested by regional and global stakeholders, ensuring timely delivery and alignment with business objectives. Regulatory Issue Management Identify, assess, and address regulatory issues related to assigned products, providing regulatory guidance and coordinating with internal and external stakeholders as needed. RESPONSIBILITIES Manage regulatory lifecycle activities for marketed products including shelf-life extensions, CMC variations, manufacturing site transfers, GDS updates, renewals, and other post-approval changes, ensuring timely submissions and approvals. Develop and execute short- and long-term regulatory plans for assigned products, proactively tracking milestones and approvals to ensure continuous product supply and business continuity. Build and maintain effective relationships with regulatory authorities and internal stakeholders to facilitate regulatory activities and address emerging issues. Manage regulatory maintenance activities for existing products, including safety-related updates, third-party product support, Drug Identification Mark registrations, and other compliance requirements. Collaborate closely with Global Regulatory Affairs (GRA) and regional stakeholders to ensure alignment on regulatory requirements, submissions, and implementation strategies. Execute regional and global regulatory projects, ensuring timely completion of deliverables and effective cross-functional collaboration. Monitor changes in local regulations and guidelines, assess regulatory impact, and develop appropriate compliance and implementation strategies. Provide regulatory expertise and strategic input to support business objectives while ensuring compliance with applicable regulatory requirements. REQUIREMENTS Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biology, or a related scientific discipline. Minimum 3+ years (Preferred) of Regulatory Affairs experience within the pharmaceutical industry, including end-to-end management of regulatory submissions and post-approval changes. Strong knowledge of Korean regulatory requirements, registration procedures, and applicable guidelines. Experience in health authority interactions and regulatory review processes. Demonstrated ability to manage multiple projects and stakeholders effectively. Effective English communication skills with experience collaborating with global and regional teams. Strong analytical, planning, and problem-solving capabilities with a proactive approach to regulatory compliance and risk management. *LI-GSK Skills Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance 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. We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels. 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