Regulatory Specialist (CMC) Clinical Development
Company: Actalent Agency
- Location: Basel, Switzerland
- Work mode: Hybrid
- Seniority: Senior
- Employment type: Contract
- Posted: 4 days ago
- Offer language: English
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.
- Fluent English (C1).
Nice to Have
- Experience within a large global pharmaceutical environment.
- Experience with biologics.
- German language skills.
Contract Details
- Duration: 12 months (extension likely)
- Location: Basel area
- Workload: 100%
- Hybrid model with minimum 50% onsite presence
