Regulatory Specialist (7147)

Join a Global Leader in Healthcare Innovation

Partner with a leading Swiss multinational healthcare company headquartered in Basel, Switzerland. As one of the world’s largest biotech companies and a global leader in in-vitro diagnostics and cancer treatments, this organization is dedicated to transforming healthcare for patients worldwide through sustainable innovation. With a strong focus on personalized healthcare, the company has played a major role in developing treatments for oncology, immunology, infectious diseases, and neuroscience.

Opportunity Overview

We are seeking three Regulatory Affairs Specialists to join the Basel headquarters. This role offers an initial contract of 12 months with high chances of extension to an unlimited contract. In this position, you will support critical submission activities, manage Health Authority interactions, and collaborate across global teams. You will partner with key stakeholders and work on both synthetic and biologic products across the full product lifecycle, from early clinical development through commercial post-marketing.

Role Focus Areas

• Early Clinical Stage Development: One position focused on supporting Investigational Medicinal Products (IMPs) and Investigational Medicinal Product Dossiers (IMPDs).
• Commercialized Products: Two positions focused on post-approval regulatory maintenance, system integration, and legacy data clean-up.

Main Responsibilities

• Independently manage and execute global technical regulatory submissions for clinical and commercial products, ensuring compliance with local/regional registration requirements and audit standards.
• Oversee end-to-end regulatory lifecycle management and evaluate technical change records for regulatory impact.
• Maintain CMC documentation in Veeva.
• Serve as the primary Pharma Technical Regulatory representative on cross-functional teams, providing regulatory advice and collaborating with global stakeholders.
• Partner with local and global technical teams to ensure continuous compliance; recommend strategies for early CTA approvals and lifecycle extensions.
• Conduct direct communications with regulatory authorities and external partners on assigned technical matters.
• Proactively identify regulatory risks, optimize tracking systems, and lead workflow simplification efforts.
• Monitor changing global regulatory guidelines and assess potential impacts on product portfolios.

Qualifications and Experience

• Relevant Swiss working/residency permit or Swiss/EU-Citizenship required.
• Minimum Bachelor’s degree in a relevant field.
• At least 3 years of CMC regulatory and technical regulatory experience.
• Solid knowledge of Veeva and Veeva Document Management for regulatory submissions.
• Prior experience in the pharmaceutical industry or with global healthcare organizations; experience with Biologics would be an asset.

Specific Position Requirements

Early Clinical Stage Position

• Experience in CMC regulatory support for early clinical trials, IMPD preparation, and clinical regulatory submissions.
• Hands-on experience with Veeva Document Management for regulatory submissions.
• Experience with Clinical Trial Applications for early to mid-stage programs.

Commercialized Products Positions

• Experience with commercialized products, post-approval regulatory maintenance, and system integration.
• Experience with legacy/old product data clean-up.
• Knowledge of post-marketing submissions, change controls, and managing regulatory deviations.
• Strong proficiency in Veeva RIM (Regulatory Information Management).
• Proactive problem-solving mindset with ability to streamline records and ensure compliance.