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
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Regulatory Specialist (CMC) Clinical Development in Basel Arbeitgeber: Actalent
Actalent ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Burnsville, Minnesota, eine dynamische und kollaborative Arbeitsumgebung bietet. Mit einem starken Fokus auf technische Exzellenz und kontinuierliche Verbesserung ermöglicht das Unternehmen seinen Mitarbeitern, an innovativen Projekten im Bereich der Luft- und Raumfahrttechnik zu arbeiten und sich beruflich weiterzuentwickeln. Die angebotenen Vorteile, einschließlich flexibler Arbeitszeiten, umfassender Gesundheitsleistungen und einer 401(k)-Rentenplanung, tragen dazu bei, dass Mitarbeiter sich geschätzt und unterstützt fühlen.
