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Associate Regulatory Affairs (m/f/d)

Basel Interim Home Office View Job Description
The role drives regulatory activities for clinical development and marketed products in Switzerland, including the planning, preparation and management of regulatory submissions with Swissmedic.It contributes to the development and execution of regulatory strategies in close collaboration with cross‑functional teams, ensuring compliant and timely progress of development programs in line with business objectives.

Added 27/04/2026

  • Prestigious biotech company
  • Temporary 6-12 month contract with option to extend or go permanent.

About Our Client

International Biotechcompany

Job Description



  • Coordinate the preparation, submission, management and maintenance of regulatory submissions related to clinical and non‑clinical development activities, including but not limited to:
    • Clinical Trial Applications (CTAs)
    • Submissions, amendments and responses to requests for information
    • Orphan Drug Designation applications
    • Paediatric Investigation Plans (PIPs)
    • Annual Reports


  • Support lifecycle management activities for marketed products, including:
    • Management of product information updates
    • Review and assessment of promotional materials
  • Collaborate closely with key internal stakeholders to ensure regulatory strategies are incorporated and implemented in line with product development objectives.
  • Assist in the preparation, coordination and execution of regulatory agency meetings, including briefing document development.
  • Manage and track regulatory questions, commitments and agency interactions; coordinate responses with subject matter experts and provide regular status updates on regulatory activities.
  • Maintain regulatory documentation within internal Regulatory Information Management Systems (RIMS), including submission tracking and document archiving.
  • Represent Regulatory Affairs at study‑level and participate in cross‑functional project teams and product development meetings.
  • Conduct regulatory research to support the development of regulatory strategies for assigned clinical development programs.
  • Maintain up‑to‑date knowledge of applicable regulatory requirements and proactively communicate regulatory changes to relevant stakeholders.



The Successful Applicant

  • 3-5 years of experience in a Regulatory Affairs role, supported by a broad scientific background.
  • Demonstrated experience working with Swissmedic, including direct interaction and regulatory correspondence.
  • Hands‑on regulatory experience with Clinical Trial Applications (CTAs) and Marketing Authorisation Applications (MAAs) in Switzerland is required.
  • Solid understanding of the drug development process, the pharmaceutical industry and the healthcare environment, including regulatory requirements and policy trends.
  • Proven ability to deliver objectives within a cross‑functional, collaborative environment, demonstrating a high level of professionalism and accountability.
  • Proficient in Microsoft Office applications (Word, Excel, PowerPoint) and Adobe systems.
  • Experience working with Document Management Systems (e.g. Documentum, Veeva Vault).
  • Familiarity with Regulatory Information Management Systems (RIMS) such as Liquent InSight, CARA, IQVIA and Veeva Vault.
  • Experience using collaboration platforms (e.g. SharePoint) and off‑the‑shelf or plug‑in software tools (e.g. StartingPoint Templates).



What's on Offer

Are you interested in contributing your regulatory experience to a prestigious and international company ?
If so, I look forward to receiving your application.

Quote job ref
JN-042026-7004758

Job summary

Job Function
Healthcare & Life Sciences
Specialisation
Biotechnology
Industry
Healthcare / Pharmaceutical
Location
Basel
Contract Type
Interim
Job Reference
JN-042026-7004758
Job Nature
Home Office

PageGroup is an equal opportunity employer committed to workforce diversity, both as an employer as well as a recruitment service provider. Each recruitment decision we make for people we hire and people we place into new roles is based solely on the candidates’ knowledge, experience and skills.