Regulatory Compliance Specialist overseeing compliance for Arc'teryx raw materials and goods. Collaborating across teams to uphold regulatory frameworks and ensure consumer safety with legal standards in focus.
TK
Hybrid Regulatory Affairs Manager – Generics
Posted 2 months ago
About the role
- Regulatory Affairs Manager handling the drug approval process and compliance documentation for a leading global pharma company based in Munich with hybrid work.
Responsibilities
- Independent responsibility for managing regulatory procedures for medicinal product approvals
- Preparation of regulatory submission documentation in eCTD format and submission to regulatory authorities
- Life-cycle management (renewals, variations)
- Direct contact with regulatory authorities and serving as the point of contact for internal and external Regulatory Affairs queries
- Maintenance and optimization of the regulatory information database
- Drafting and reviewing product information texts
Requirements
- Completed degree (e.g., pharmaceutical or natural sciences)
- Professional experience in Regulatory Affairs
- Excellent German and English language skills
- Analytical thinking, quick comprehension, and strong organizational skills
- Team player with strong communication skills
Benefits
- Flexible working arrangements (including remote work)
- 30 days of vacation + 3 bridge days
- A supportive team
- Attractive salary and comprehensive social benefits (including retirement and healthcare benefits)
- Excellent training and development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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