Regulatory Specialists

Shape Global Regulatory Strategy for Life-Changing Medicines

Join a dynamic team in Switzerland on a contract basis to drive technical regulatory affairs, with a specific focus on Chemistry, Manufacturing, and Controls (CMC). This role offers the opportunity to work across the entire product lifecycle, playing a key part in managing global submissions, ensuring compliance, and collaborating with cross-functional teams to support both clinical and commercial products. Candidates must hold the right to work in this location or possess an EU passport.

Core Responsibilities

• Manage and execute global technical regulatory submissions for clinical and commercial products, ensuring strict compliance with local and regional requirements.
• Oversee regulatory lifecycle management for assigned products, including evaluating change records and maintaining CMC documentation within Veeva systems.
• Represent Pharma Technical Regulatory (PTR) on cross-functional project teams, providing expert regulatory advice and assessing potential 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 the ability to streamline processes.

Role-Specific Requirements

Position 1: Clinical Focus (Early-Stage Development)

• Experience supporting Investigational Medicinal Products (IMPs) and Investigational Medicinal Product Dossiers (IMPDs).
• Hands-on experience with early clinical trial submissions and CTAs.

Position 2: Commercial Focus (Post-Marketing and 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.

Additional Qualifications

• German language skills.
• Prior experience in biologics.