CMC Regulatory Specialist – Clinical Submissions

Flexsis; Basel; On-site; CHF 110,000 - 160,000; Full time

Job summary

Flexsis in Basel, Switzerland is seeking a Regulatory Specialist (m/f/d) focusing on CMC regulatory activities for clinical and early-stage development. The role is full-time in Basel with a 12-month contract, likely extendable, and an earliest start date soon with 1 February 2027 latest.

You will support global regulatory submissions for investigational medicinal products, work with cross-functional teams and stakeholders, and ensure high-quality documentation and timely clinical submissions in

Qualifications

• Bachelor's degree or higher in a relevant field.
• 3–4 years of experience in CMC Regulatory Affairs or Technical Regulatory Affairs.
• Experience supporting clinical development programs and preparing/maintaining IMPDs.
• Experience with Clinical Trial Applications (CTAs) and clinical regulatory submissions.
• Hands-on experience with Veeva Document Management for regulatory submissions.

Responsibilities

• Prepare, coordinate and manage global CMC regulatory submissions for early- to mid-stage clinical development programs.
• Prepare and maintain IMPDs and related CMC documentation.
• Support CTAs and other clinical regulatory submissions.
• Manage regulatory submission documentation and workflows using Veeva DM.
• Assess regulatory impact of technical changes and support change control processes.
• Collaborate with global teams and external partners to ensure regulatory compliance.
• Support interactions with Health Authorities and regulatory strategies for clinical programs.
• Identify regulatory risks and contribute to process improvements.

Skills

Regulatory Affairs

English proficiency

Analytical skills

Communication

Organizational skills

Education

Bachelor's degree or higher

Tools

Veeva Document Management

Job description

Flexsis in Basel, Switzerland is seeking a Regulatory Specialist (m/f/d) focusing on CMC regulatory activities for clinical and early-stage development. The role is full-time in Basel with a 12-month contract, likely extendable, and an earliest start date soon with 1 February 2027 latest.

You will support global regulatory submissions for investigational medicinal products, work with cross-functional teams and stakeholders, and ensure high-quality documentation and timely clinical submissions in