Regulatory Affairs Manager – Focus on Biosimilars
TRIGA Consulting GmbH & Co. KG
full-time
Posted on:
Location Type: Hybrid
Location: Frankfurt • Germany
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About the role
- Implement global regulatory requirements at the national level in close coordination with international Regulatory Affairs teams
- Prepare, review and maintain regulatory submission documents
- Maintain external portals (e.g., medicinal product listings and information services)
- Support artwork changes and implement regulatory updates throughout the product lifecycle
- Stay up to date on regulatory developments and communicate relevant information to internal stakeholders
- Ensure traceable documentation within the existing document management system (DMS)
Requirements
- University degree (natural sciences, pharmacy, or equivalent)
- Professional experience in Regulatory Affairs for human medicinal products
- Ideally experience with centralized authorization procedures and international interfaces
- Fluent German (C1) and good English skills
- Structured and meticulous working style
Benefits
- Attractive salary and comprehensive additional benefits (e.g., pension plan)
- Flexible working hours and 2 days remote work per week
- Extensive training and development opportunities
- Job ticket, company bike (JobRad), and more
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submission documentsregulatory updatesdocument management systemcentralized authorization proceduresmedicinal product listings
Soft Skills
structured working stylemeticulous working stylecommunication skills
Certifications
university degree in natural sciencesuniversity degree in pharmacy