Regulatory Affairs Manager
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Seoul • South Korea
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About the role
- Ensure products enter and remain on the market with compliant, commercially aligned claims, while meeting all internal and external regulatory requirements.
- Analyze regulatory issues and communicate effectively with key stakeholders, including global colleagues.
- Lead the preparation of regulatory documents, dossiers, and applications.
- Support the development of the strongest claims and promotion possible within the regulations.
- Actively contribute to high‑performing teams, including identifying ways to improve performance.
- Manage compliance within portfolio/activity streams.
Requirements
- 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.
Benefits
- 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.
- Train other company stakeholders as required.
- Maintain a high level of knowledge on the science of the products.
- 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.
- Manage compliance within portfolio/activity streams in accordance with Novo Nordisk expectations.
- Propose and implement solutions to identified issues.
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsregulatory approvalsregulatory documentsdossiersapplications
Soft skills
strategic thinkingstakeholder managementproblem-solvingcommunication
Certifications
pharmacist license