Compliance Officer in financial services managing regulatory checks and risk assessments. Operative role with development perspective in a hybrid work setting.
TK
Hybrid Regulatory Affairs Manager – Generics
Posted 2 hours ago
About the role
- Regulatory Affairs Manager managing drug approval processes for a successful pharmaceutical company. Responsible for documentation submission and lifecycle management in compliance with regulations.
Responsibilities
- Independently manage procedures for medicinal product approvals
- Prepare regulatory submission documentation in eCTD format and submit to authorities
- Life-cycle management (renewals, variations)
- Direct contact with regulatory authorities and point of contact for internal and external RA queries
- Maintain and optimize the regulatory information database
- Prepare 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 remote work)
- 30 days annual leave + 3 bridge days
- A friendly team
- Attractive salary & comprehensive social benefits (including pension and health coverage…)
- Excellent training and development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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