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.
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