Regulatory Specialist / Regulatory Specialistess

Join Our Team as a Regulatory Affairs Specialist

CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We empower careers by connecting talented professionals with meaningful opportunities, while assisting our clients in engaging, retaining, and developing the right talent when needed.

Our client, a leading Swiss multinational healthcare company headquartered in Basel, Switzerland, operates in the Pharmaceuticals and Diagnostics sectors. It ranks among the world’s largest biotech firms and is a global leader in in-vitro diagnostics and cancer treatments. Renowned for its strong focus on innovation, particularly in personalized healthcare, our client has substantially contributed to advancements in oncology, immunology, infectious diseases, and neuroscience.

Position Overview

We are currently seeking three Regulatory Affairs Specialists for our Basel HQ, offering an initial 12-month contract with strong potential for extension to an unlimited contract.

In this role, you will support essential submission activities, manage Health Authority interactions, and contribute to transforming healthcare for patients worldwide through sustainable innovation. You will collaborate across global teams, partner with key stakeholders, and work on both synthetic and biologic products throughout the full product lifecycle, from early clinical development to commercial post-marketing.

Available Positions

• One position: Focused on early clinical stage development, supporting Investigational Medicinal Products (IMPs) and Investigational Medicinal Product Dossiers (IMPDs).
• Two positions: Focused on commercialized products, 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 and regional registration requirements and audit standards.
• Oversee end-to-end regulatory lifecycle management while evaluating technical change records for regulatory impact.
• Maintain CMC documentation in Veeva.
• Act 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, particularly with Biologics, is a valuable asset.

Position-Specific Qualifications

For Position One:

• 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.

For Position Two:

• 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 the ability to streamline records and ensure compliance.

Apply Online

If you would like to learn more about CTC and the opportunities outlined, please apply online using the form below. Only applications matching the job profile will be considered.