Regulatory Specialist

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

Regulatory Specialist (m/f/d) – Clinical / Early-Stage Development (CMC)

For our client, an internationally renowned company in the pharmaceutical and healthcare industry, we are looking for a Regulatory Specialist (m/f/d) with a focus on CMC regulatory activities in clinical and early-stage development. This is a full-time position based in Basel, Switzerland, with an initial contract duration of 12 months and a likely possibility of extension. The ideal candidate would be available to start as soon as possible, with 1 February 2027 being the latest possible start date.

About the Role

In this role, you will support global regulatory submissions for investigational medicinal products and contribute to the successful progression of clinical development programs. You will work closely with cross-functional teams and international stakeholders to ensure high-quality regulatory documentation, compliance with applicable requirements and the timely execution of clinical submissions.

Key Responsibilities

• Prepare, coordinate and manage global CMC regulatory submissions for early- to mid-stage clinical development programs.
• Prepare, review and maintain Investigational Medicinal Product Dossiers (IMPDs) and related CMC documentation.
• Support Clinical Trial Applications (CTAs) and other clinical regulatory submissions.
• Manage regulatory submission documentation and workflows using Veeva Document Management.
• Assess the regulatory impact of technical changes and support relevant change control processes.
• Collaborate with global technical teams, regulatory colleagues and external partners to ensure compliance with applicable regulatory requirements.
• Support interactions with Health Authorities and contribute to regulatory strategies for clinical development programs.
• Identify potential regulatory risks and contribute to process improvements and operational efficiency.
• Monitor relevant regulatory guidelines and assess their impact on ongoing clinical development activities.

Your Profile

• Bachelor's degree or higher in a relevant scientific, pharmaceutical or technical discipline.
• 3–4 years of professional experience in CMC Regulatory Affairs or Technical Regulatory Affairs.
• Practical experience supporting clinical development programs and preparing or maintaining IMPDs.
• Experience with Clinical Trial Applications and clinical regulatory submissions.
• Hands-on experience with Veeva Document Management, particularly in the context of regulatory submissions.
• Solid understanding of global regulatory requirements for investigational medicinal products.
• Fluent in English, both written and spoken (minimum C1 level).
• Strong analytical and organizational skills, with a structured and independent working style.
• Excellent communication skills and the ability to collaborate effectively with international, cross-functional teams.

Nice to Have

• Experience with biologics.