Job Description

Regulatory Affairs Manager (Team Manager)

Regulatory Affairs

Seoul, Korea

Are you passionate about regulatory compliance and ensuring the safety of pharmaceutical products? Do you have the leadership skills to guide a team of experts in a fast-paced and dynamic environment? If so, we invite you to join our team as a Regulatory Affairs Manager in Korea. Read more and apply today!

Your new role

This role reports to the Regulatory Affairs (RA) & Pharmacovigilance (PV) Head and leads a team of 4–5 (Senior) Regulatory Affairs Specialists. As Regulatory Affairs Manager, you will ensure products enter and remain on the market with compliant, commercially aligned claims, while meeting all internal and external regulatory requirements.

You will lead the local regulatory team, partner proactively with internal stakeholders, and represent Novo Nordisk in engagements with regulators, trade associations, and other external bodies. The role also involves identifying opportunities, solving regulatory challenges, driving improvement initiatives, and contributing to regulatory strategies and compliance enhancements.

The role tasks include but are not limited to:

• Lead and oversee the preparation of new regulatory documents, dossiers, and applications to enable new products to be launched and maintained in the market, ensuring correct alignment and compliance with regulations while proactively seeking innovative and rapid pathways to market.
• Analyze regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead the development of strategies and plans to mitigate risks so that we can deliver products backed by science that are robust and aligned with business needs.
• Actively contribute to high‑performing teams, including identifying ways to improve performance. Lead direct reports and/or cross‑functional teams within the local market.
• Build relationships with key stakeholders and represent Novo Nordisk in a responsible manner, in line with company values, to communicate Novo Nordisk policies and strategies and negotiate outcomes. Manage compliance within portfolio/activity streams in accordance with Novo Nordisk expectations. Propose and implement solutions to identified issues.
• Collaboratively work with other functions (e.g., marketing, supply chain) as a functional leader from RA to deliver NDA (New Drug Application) and value engineering projects. Support the development of the strongest claims and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
• Proactively identify potential regulatory risks and manage the impact of regulatory changes within the defined scope of responsibility on the business and beyond to support the RA&PV Head. Maintain required regulatory compliance databases, systems, and processes.
• Train other company stakeholders as required. Maintain a high level of knowledge on the science of the products. Communicate independently on a daily basis with the MFDS (Korean Ministry of Food and Drug Safety) and with other teams/departments regarding assigned tasks.

Your new department
You will be part of the Regulatory Affairs team at Novo Nordisk, a dynamic and collaborative group dedicated to ensuring regulatory compliance and patient safety. Our team plays a crucial role in gaining regulatory approval for clinical trials, new drugs, devices, and digital health solutions. We also work to expand the availability of existing products and shape future regulatory frameworks through dialogues with health authorities and policymakers. Based at our headquarters, you will join a fast-paced and innovative environment where your contributions will make a meaningful impact on patients' lives.

Your skills & qualifications
We are looking for a candidate who meets the following qualifications:

• Must hold a pharmacist license and have 9+ years of work experience in regulatory submissions/approvals.
• Experience in people management is preferred.
• Regulatory experience in a multinational company is a plus.
• Possesses strong strategic thinking, stakeholder management, and problem‑solving skills.
• Demonstrates a good command of English and exhibits persuasive and impactful communication.

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

Deadline
Until the end of recruitment. Applications are reviewed on an ongoing basis.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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