Regulatory Specialist (CMC) – Clinical Development & Early-Stage Programs

For our client, we are seeking an experienced Regulatory Specialist (CMC) to support global early-stage clinical development programs. This position focuses on regulatory activities related to Investigational Medicinal Products (IMPs), Clinical Trial Applications (CTAs), and CMC documentation for products in development.

You will act as a key partner across technical development, manufacturing, quality, and regulatory functions to ensure successful submission and maintenance of clinical regulatory dossiers worldwide.

General Information

Location: Basel, Switzerland

Workload: 100%

Hybrid Model: Minimum 50% onsite

Contract Duration: 12 months

Extension: Likely

Start Date: ASAP

Latest Start Date: February 1, 2027

Department: Pharma Technical Regulatory (PTR)

Responsibilities

• Manage and execute global CMC regulatory submissions for clinical-stage products.
• Prepare and maintain regulatory dossiers supporting clinical development programs.
• Support the preparation of IMPDs, CTAs, and related regulatory documentation.
• Ensure compliance with global regulatory requirements and internal quality standards.
• Assess technical changes for regulatory impact and support implementation activities.
• Collaborate with manufacturing, quality, development, and regulatory stakeholders.
• Represent Technical Regulatory Affairs within cross-functional project teams.
• Contribute to regulatory strategies supporting clinical development milestones.
• Support interactions with global Health Authorities and external partners.
• Monitor regulatory trends and evaluate their impact on ongoing development programs.
• Drive continuous improvement initiatives within regulatory processes and systems.

Required Qualifications

• Bachelor's degree or higher in Life Sciences, Pharmacy, Biotechnology, Chemistry, or a related scientific discipline.
• Minimum 3–4 years of experience in CMC Regulatory Affairs or Technical Regulatory Affairs.
• Strong experience with clinical-stage pharmaceutical development.
• Experience preparing and managing IMPDs and Clinical Trial Applications (CTAs).
• Knowledge of Investigational Medicinal Product (IMP) requirements.
• Hands-on experience with Veeva Vault and/or Veeva Document Management.
• Excellent English communication skills (minimum C1 level).
• Strong organizational and stakeholder management capabilities.

Preferred Qualifications

• Experience supporting IND submissions.
• Experience with biologics.
• Previous experience within a global pharmaceutical or biotechnology environment.
• German language skills are considered an advantage.