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Regulatory Affairs Consultant - on-site in Basel (German and French language skills)
応募 求人ID R0000046397 ロケーション バーゼル, Kanton Basel-Stadt 仕事内容We are seeking an experienced Regulatory Affairs Consultant to join our global Regulatory Affairs team. In this role, you will develop, review, and manage regulatory submissions and compliance activities for pharmaceutical products throughout their lifecycle—from clinical development through post-market activities. You will work collaboratively with cross-functional teams while demonstrating strong independent judgment and operational expertise.
This is a client dedicated role and you will be working from an office 2 days a week (Basel).
Key Responsibilities:
Develop, contribute to, and review content and format for regulatory submissions according to Swiss regulatory guidelines, including:
- Major and minor submissions
- Periodic Safety Update Reports (PSURs)
- Label changes and Chemistry, Manufacturing & Controls (CMC) variations
- Post-approval commitments, variations, and notifications
- Collaborate with the Swiss regulatory team, Global Regulatory Science, Regulatory CMC, and cross-functional project teams to develop and execute regulatory strategy throughout the product lifecycle, including clinical development, post-market activity, and life cycle management.
- Coordinate regulatory submission aspects relevant to assigned projects and programs.
- Maintain Swiss labeling (SmPC, PIL, artwork, and packaging in local languages) in alignment with regulatory requirements and global labeling/core datasheet standards.
- Demonstrate strong ability to work both independently and collaboratively within project teams to achieve group goals.
- Support the Head of Regulatory Affairs Switzerland in regulatory activities as appropriate.
Skills and Qualifications:
- University Degree in Life Sciences or related discipline
- 5-8+ years of professional experience in Regulatory Affairs (Marketing Authorization Applications and post-approval variations)
- Strong, current knowledge of Swissmedic regulations (mandatory)
- Proven experience in preparing major regulatory submissions and variation packages to Swissmedic
- Strong experience with CTD format and eCTD submission builds
- Experience in biologics and vaccines development - preferred
- Knowledge of Rare Diseases, Autoimmune Diseases, or Oncology therapeutic areas - preffered
- Fluent spoken and written German, French and English
