Novo Nordisk is looking for a Senior Regulatory Affairs Specialist to ensure our products enter and remain on the market with compliant claims aligned to commercial plans. You will be a key member of the local regulatory team, partnering with stakeholders, representing Novo Nordisk to external bodies, and proactively driving improvements and regulatory strategies.
What You'll Do
- Lead the preparation of regulatory documents, dossiers, and applications to enable new product launches and maintenance, ensuring compliance and seeking innovative paths to market.
- Analyze regulatory issues and communicate effectively with key stakeholders, including global colleagues. Develop and lead strategies to mitigate risks.
- Actively contribute to high performing teams and may lead cross-functional teams within the local market.
- Build relationships with key stakeholders, represent Novo Nordisk, and manage compliance within portfolio/activity streams.
- Collaborate with other functions (e.g., marketing, supply chain) to deliver New Drug Application (NDA) and value engineering projects.
- Proactively identify potential regulatory risks and manage the impact of regulatory changes.
- Maintain required regulatory compliance databases, systems, and processes.
- Train other company stakeholders to build knowledge and maintain a high level of knowledge on product science.
- Have daily independent communication with MFDS (Korean Ministry of Food and Drug Safety) and other teams.
What We're Looking For
- Must hold a pharmacist license.
- 5-10 years of work experience in regulatory submissions/approvals.
- Work experience in new product registration and GMP inspection is a must.
- Possesses strong time management, analytical thinking and problem-solving skills.
- Demonstrates a good command of English and exhibits persuasive and impactful communication.
Nice to Have
- Regulatory experience in a multinational company is a plus.
Team & Environment
You will be part of the Regulatory Affairs team, reporting to the Regulatory Affairs Manager. Our culture seeks solutions to defeat serious chronic diseases and promote long-term health. We approach work with an unconventional spirit, determination, and curiosity, focusing on collective passion, mutual respect, and willingness to go beyond known limits.
Work Mode
This is an on-site position located in Seoul, Korea.
Novo Nordisk is an equal opportunity employer.
