Regulatory Specialist (CMC) Clinical Development

Actalent; Basel; Hybrid; CHF 120,000 - 160,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Actalent is seeking a Regulatory Specialist (CMC) to drive global regulatory submissions for clinical-stage products and to support IMPDs, CTAs and related CMC documentation. You will liaise with cross-functional teams across development, manufacturing and quality to ensure alignment with Health Authority expectations.

The role requires 3–4+ years in CMC Regulatory Affairs, strong Veeva experience, and the ability to operate in a Basel-area, hybrid work environment with substantial onsite

Qualifications

• Bachelor's degree in a relevant scientific field.
• 3–4+ years of CMC Regulatory Affairs experience.
• Experience supporting IMPs, IMPDs and CTAs.
• Experience with technical regulatory submissions for clinical development programs.
• Strong knowledge of Veeva Document Management.

Responsibilities

• Manage and execute global regulatory submissions for clinical-stage products.
• Support IMPD preparation and maintenance with related documentation.
• Contribute to CTAs and other early-phase regulatory submissions.
• Assess regulatory impact of technical changes and maintain docs in Veeva.
• Act as regulatory representative within cross-functional project teams.
• Collaborate with development, manufacturing, quality and regulatory stakeholders globally.
• Support Health Authority interactions and regulatory communications.

Skills

CMC Regulatory Affairs

Regulatory Submissions

Veeva Knowledge

Cross-functional Collaboration

Education

Bachelor's degree in Science

Tools

Veeva

Job description

Our client is a global leader in the pharmaceutical industry, committed to advancing science and delivering innovative therapies to patients worldwide. To support ongoing clinical development activities, we are looking for a Regulatory Specialist (CMC) with experience in early-stage development and clinical regulatory submissions.

In this role, you will support global CMC regulatory activities for investigational products, working closely with cross-functional teams to ensure high-quality submissions and successful interactions with Health Authorities.

Responsibilities

• Manage and execute global technical regulatory submissions for clinical-stage products.
• Support the preparation and maintenance of Investigational Medicinal Product Dossiers (IMPDs) and related documentation.
• Contribute to Clinical Trial Applications (CTAs) and other early-phase regulatory submissions.
• Assess regulatory impact of technical changes and maintain documentation in Veeva.
• Act as a key regulatory representative within cross-functional project teams.
• Collaborate with development, manufacturing, quality, and regulatory stakeholders globally.
• Support Health Authority interactions and regulatory communications.
• Monitor evolving regulatory requirements and evaluate potential impacts on development programs.

Requirements

Must Have

• Bachelor's degree in a relevant scientific discipline.
• 3-4+ years of CMC Regulatory Affairs experience.
• Experience supporting IMPs, IMPDs and Clinical Trial Applications (CTAs).
• Experience with technical regulatory submissions for clinical development programs.
• Strong knowledge of Veeva Document Management.

Nice to Have

• Experience within a large global pharmaceutical environment.
• Experience with biologics.
• Location: Basel area
• Hybrid model with minimum 50% onsite presence