Regulatory Affairs Specialists (7147)

CTC Resourcing Solutions; Basel; On-site; CHF 100,000 - 140,000; Full time

Job summary

CTC is seeking Regulatory Affairs Specialists for Basel HQ to support critical submissions for early clinical and commercial products. Two roles focus on post‑approval maintenance and data clean‑up, while one role targets IMPD/IMPD for early clinical programs.

You will collaborate with global teams and manage global registrations across the lifecycle. The positions require Swiss working permit or Swiss/EU citizenship, a bachelor’s degree, and at least 3 years in CMC regulatory work.

Qualifications

• 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.
• Experience in pharma or global healthcare organizations; Biologics experience is a plus.

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; 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.

Skills

Regulatory submissions

Cross-functional collaboration

Regulatory risk awareness

Education

Bachelor’s degree in a relevant field

Tools

Veeva Document Management

Veeva RIM

Job description

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

Our client is a leading Swiss multinational healthcare company headquartered in Basel, Switzerland. Operating in Pharmaceuticals and Diagnostics, it is one of the world’s largest biotech companies and a global leader in in‑vitro diagnostics and cancer treatments. Our client is known for its strong focus on innovation, particularly in personalized healthcare, and has played a major role in developing treatments for oncology, immunology, infectious diseases, and neuroscience.

For their Basel HQ we are currently looking for three:

Regulatory Affairs Specialists

offering an initial contract of 12 months with high chances of extension to an unlimited contract.

In this role, you will support critical 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 across the full product lifecycle, from early clinical development through commercial post‑marketing.

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/regional registration requirements and audit standards.
• Oversee end‑to‑end regulatory lifecycle management; 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 and experience with Biologics would be an asset.

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 ability to streamline records and ensure compliance.