Senior Specialist, Global Regulatory Affairs CMC
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full-time
Posted on:
Location Type: Office
Location: Copenhagen • 🇩🇰 Denmark
Visit company websiteJob Level
Senior
About the role
- Support regulatory CMC activities for multiple Lundbeck products
- Provide input on regulatory CMC strategy
- Collaborate with key stakeholders to prepare regulatory submissions and Health Authority communications
- Coordinate multiple projects in a fast and results-oriented environment
Requirements
- BA/BS degree in a scientific/engineering discipline
- 15+ years of experience in the pharmaceutical industry
- Experience with CTD format and content regulatory filings including NDA and MAA
- Effective communication and interpersonal skills to effectively collaborate with cross-functional teams and external stakeholders
- Informal approach to stakeholders and colleagues
Benefits
- Inspiring workplace
- Passionate colleagues
- Collaborative culture
- Mix of exciting tasks
- Numerous development opportunities
- Initiatives focused on well-being
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory CMC activitiesregulatory submissionsCTD formatNDAMAA
Soft skills
effective communicationinterpersonal skillscollaborationstakeholder engagementproject coordination
Certifications
BA/BS degree