Global CMC Regulatory Specialist (12-Month Contract)

Manpower Switzerland; Basel; On-site; CHF 110,000 - 140,000; Full time

Job summary

Manpower Switzerland seeks an experienced Regulatory Specialist (CMC) to support lifecycle management, regulatory compliance, and post-approval activities for commercial pharmaceutical products. The role emphasizes managing change controls, deviations, and remediation within global systems.

The ideal candidate will have a Life Sciences background and 3–4 years in CMC/technical regulatory affairs, with strong Veeva RIM knowledge and experience in post-approval activities.

Qualifications

• Bachelor’s degree or higher in Life Sciences, Pharmacy, Biotechnology, Chemistry, or related field.
• 3–4 years of experience in CMC regulatory or technical regulatory affairs.
• Experience supporting commercial pharmaceutical products.
• Post-approval maintenance and lifecycle management experience.
• Experience with change controls, regulatory deviations, and variations; strong knowledge of Veeva RIM.

Responsibilities

• Manage global CMC regulatory submissions and post-approval activities for commercial products.
• Evaluate technical changes and determine regulatory impact.
• Manage change controls, regulatory deviations, and maintenance submissions.
• Maintain and update regulatory documentation within Veeva systems.
• Support remediation projects, legacy data reviews, and regulatory record clean-up initiatives.
• Ensure ongoing compliance with global and regional regulatory requirements.
• Serve as the primary regulatory representative within cross-functional project teams.
• Identify regulatory risks and develop practical mitigation strategies.
• Collaborate with manufacturing, quality, supply chain, and regulatory stakeholders globally.
• Drive process optimization and operational excellence initiatives.
• Monitor evolving regulatory requirements and assess business impact.

Skills

CMC regulatory affairs

Regulatory submissions

Lifecycle management

Education

Bachelor’s degree or higher in Life Sciences, Pharmacy, Biotechnology, Chemistry, or related field

Tools

Veeva RIM

Job description

Manpower Switzerland seeks an experienced Regulatory Specialist (CMC) to support lifecycle management, regulatory compliance, and post-approval activities for commercial pharmaceutical products. The role emphasizes managing change controls, deviations, and remediation within global systems.

The ideal candidate will have a Life Sciences background and 3–4 years in CMC/technical regulatory affairs, with strong Veeva RIM knowledge and experience in post-approval activities.