Senior Regulatory Affairs Specialist
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Seoul • 🇰🇷 South Korea
Visit company websiteJob Level
Senior
About the role
- Ensure products enter and remain on the market with compliant claims
- Lead the preparation of regulatory documents, dossiers, and applications
- Analyze regulatory issues and communicate effectively with key stakeholders
- Develop and lead strategies and plans to mitigate risks
- Build relationships with key stakeholders and represent Novo Nordisk
Requirements
- Must hold a pharmacist license
- 5-10 years of work experience in regulatory submissions/approvals
- Work experience in new product registration and GMP inspection
- Regulatory experience in a multinational company is a plus
- Possesses strong time management, analytical thinking and problem-solving skills
- Demonstrates a good command of English
- Exhibits persuasive and impactful communication
Benefits
- Proactively drive improvements and regulatory strategies
- Collaboratively work together with other functions
- Support the development of the strongest claims and promotion possible
- Maintain high level of knowledge on the science of products
- Maintain required regulatory compliance databases, systems and processes
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsregulatory approvalsnew product registrationGMP inspectionregulatory documentsdossiersapplications
Soft skills
time managementanalytical thinkingproblem-solvingpersuasive communicationimpactful communication
Certifications
pharmacist license