• 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 Function

Healthcare & Life Sciences

Specialisation

Biotechnology

Industry

Healthcare / Pharmaceutical

Location

Basel

Contract Type

Interim

Job Reference

JN-042026-7004758

Job Nature

Home Office