Novo Nordisk is looking for a Regulatory Affairs Manager to ensure our products enter and remain on the Korean market with compliant, commercially aligned claims. In this role, you will lead the local regulatory team to meet all internal and external requirements, reporting to the Regulatory Affairs (RA) & Pharmacovigilance (PV) Head. We are a company driven by a determination to defeat serious chronic diseases through lasting change.
What You'll Do
- Lead and oversee the preparation of new regulatory documents, dossiers, and applications for product launches and maintenance, seeking innovative pathways to market.
- Analyze regulatory issues and communicate with global colleagues and key stakeholders to develop strategies and mitigate risks.
- Actively contribute to high-performing teams, lead direct reports and/or cross-functional teams, and identify ways to improve performance.
- Build relationships with key stakeholders, represent Novo Nordisk with regulators and trade associations, and manage compliance within your portfolio.
- Collaborate with functions like marketing and supply chain as a functional leader from RA to deliver NDA and value engineering projects.
- Proactively identify potential regulatory risks, manage the impact of regulatory changes, and maintain required compliance databases, systems, and processes.
- Train other company stakeholders, maintain a high level of product science knowledge, and communicate daily with the MFDS and internal teams.
What We're Looking For
- Must hold a pharmacist license.
- 9+ years of work experience in regulatory submissions and approvals.
- Strong strategic thinking, stakeholder management, and problem-solving skills.
- Good command of English and persuasive, impactful communication.
Nice to Have
- Experience in people management.
- Regulatory experience in a multinational company.
Team & Environment
You will lead a team of 4–5 (Senior) Regulatory Affairs Specialists and be part of the broader Regulatory Affairs team. This position reports directly to the Regulatory Affairs (RA) & Pharmacovigilance (PV) Head.
Work Mode
This is a local, Seoul-based position in Korea.
Novo Nordisk values diverse thinking, shared purpose, and mutual respect and is an equal opportunity employer.
