Vendor Compliance Analyst coordinating Oracle solutions and troubleshooting customer scorecards at Helen of Troy. Collaborating with internal teams to ensure compliance and address issues efficiently.
TK
Hybrid Regulatory Affairs Manager – Generics
Posted 4 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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