Hybrid CMC Regulatory Specialist - Clinical Submissions

Actalent; Basel; Híbrido; CHF 120 000 - 160 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work model

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

CMC Regulatory Affairs

Regulatory Submissions

Veeva Knowledge

Cross-functional Collaboration

Formação académica

Bachelor's degree in Science

Ferramentas

Veeva

Descrição da oferta de emprego

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