Regulatory Affairs Specialist overseeing regulatory submissions in SEA for global medical device company. Ensuring compliance and managing stakeholder communications for product regulations.
TK
Hybrid Regulatory Affairs Manager – Focus on Biosimilars
Posted 2 weeks ago
About the role
- Regulatory Affairs Manager implementing global regulatory guidelines for biopharmaceutical products. Managing documents and changes while coordinating with international teams for compliance.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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