Compliance Analyst monitoring programmatic and financial compliance for contracts at a CPA firm. Collaborating with team to ensure adherence to laws and regulations.
TK
Hybrid Regulatory Affairs Manager – Generics
Posted 5 days 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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