Regulatory Affairs Manager – Focus on Biosimilars
TRIGA Consulting GmbH & Co. KG
full-time
Posted on:
Location Type: Hybrid
Location: Frankfurt • 🇩🇪 Germany
Visit company websiteJob Level
Mid-LevelSenior
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
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