Regulatory Affairs Specialist; Replacement of maternity leave, Y

JOB PURPOSE

• Plan, prepare, and submit regulatory variations for marketed products, including CMC changes, labeling updates, and maintenance of product licenses, ensuring ongoing regulatory compliance.
• Manage and execute assigned regulatory projects and activities requested by regional and global stakeholders, ensuring timely delivery and alignment with business objectives.
• Identify, assess, and address regulatory issues related to assigned products, providing regulatory guidance and coordinating with internal and external stakeholders as needed.

• 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.

• 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.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants.

Contact: APACRe