Ready to shape the global regulatory strategy behind life-changing medicines and ensure products reach patients worldwide?
Proclinical is seeking three experienced Regulatory Specialists to join a dynamic team in Switzerland, on a contract basis. This role focuses on technical regulatory affairs, particularly Chemistry, Manufacturing, and Controls (CMC), with opportunities to work across the product lifecycle. You will play a key role in managing global submissions, ensuring compliance, and collaborating with cross-functional teams to support clinical and commercial products.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Manage and execute global technical regulatory submissions for clinical and commercial products, ensuring compliance with local and regional requirements.
- Oversee the regulatory lifecycle management of assigned products, including evaluating change records and maintaining CMC documentation in Veeva systems.
- Represent Pharma Technical Regulatory (PTR) on cross-functional project teams, providing regulatory advice and assessing impacts.
- Partner with technical teams to ensure continuous compliance and develop strategies for early approvals of Clinical Trial Applications (CTAs) and lifecycle extensions.
- Communicate directly with regulatory authorities and external partners on technical matters.
- Identify regulatory risks, optimize tracking systems, and lead workflow simplification efforts to enhance operational efficiency.
- Monitor global regulatory guidelines and assess their impact on product portfolios and strategies.
Key Skills and Requirements:
- Bachelor's degree in a relevant field.
- Experience in CMC regulatory or technical regulatory affairs.
- Proficiency in Veeva Document Management systems for regulatory submissions.
- Fluent in English (C1 level).
- Strong problem-solving skills and ability to streamline processes.
Additional Role-Specific Requirements:
Position 1: Regulatory Specialist - Clinical (Early-Stage Development, CMC Focus)
- Experience supporting Investigational Medicinal Products (IMPs) and Investigational Medicinal Product Dossiers (IMPDs).
- Hands-on experience with early clinical trial submissions and CTAs.
Position 2: Regulatory Specialist - Commercial (Post-Marketing, Remediation)
- Expertise in post-approval regulatory maintenance, change controls, and managing regulatory deviations.
- Familiarity with legacy product clean-up and integration into regulatory systems.
- Proficiency in Veeva RIM environments.
Nice to Haves:
- German language skills.
- Prior experience in biologics.
If you are having difficulty in applying or if you have any questions, please contact Olivier Worch at o.worch@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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