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 5 months ago
About the role
- Regulatory Affairs Manager in an international pharmaceutical company overseeing drug approval processes and regulatory documentation. Collaborating with authorities and internal teams in Munich and home office.
Responsibilities
- Independently manage procedures for medicinal product approvals
- Prepare regulatory submission documentation in eCTD format and submit it to the authorities
- Life-cycle management (renewals, variations)
- Direct contact with regulatory authorities and serve as a point of contact for internal and external Regulatory Affairs queries
- Maintain and optimize the regulatory information database
- Draft and review product information texts
Requirements
- A 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 home office)
- 30 days annual leave + 3 bridge days
- A friendly team
- Attractive salary & comprehensive social benefits (including retirement and health provisions…)
- Excellent training and development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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