Regulatory Affairs Specialist — Basel (12‑Month Contract)

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 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.