Hybrid CMC Regulatory Specialist: Lifecycle & Post-Marketing

Actalent; Basel; Ibrido; CHF 110.000 - 170.000; Tempo pieno

Descrizione del lavoro

Actalent in the Basel area seeks a Regulatory Specialist (CMC) with 4+ years of experience to support lifecycle management, regulatory maintenance, and post-approval submissions for commercial pharmaceutical products. The role emphasizes change controls, remediation, data management in Veeva and Veeva RIM and collaboration across functions.

You will serve as regulatory liaison within cross-functional teams, coordinating with QA, manufacturing, supply chain and health authorities, driving

Competenze

• Bachelor's degree in a relevant scientific discipline.
• 4+ years of CMC Regulatory Affairs experience.
• Experience supporting commercialized pharmaceutical products.
• Experience with post-marketing submissions, lifecycle management, regulatory maintenance and change controls.
• Strong proficiency with Veeva and Veeva RIM.

Mansioni

• Manage and execute global technical regulatory submissions for commercial products.
• Support lifecycle management activities and post-approval maintenance.
• Assess change controls and determine regulatory impact.
• Manage regulatory deviations and remediation activities.
• Maintain technical documentation in Veeva and Veeva RIM.
• Support legacy data clean-up and system integration initiatives.
• Act as the regulatory representative within cross-functional project teams.
• Collaborate with quality, manufacturing, supply chain and regulatory stakeholders.
• Drive process improvements and identify opportunities to simplify workflows.
• Support communications with Health Authorities and external partners.

Conoscenze

Regulatory Affairs

Lifecycle management

Cross-functional collaboration

Formazione

Bachelor's degree in a relevant scientific discipline

Strumenti

Veeva

Veeva RIM

Descrizione del lavoro

Actalent in the Basel area seeks a Regulatory Specialist (CMC) with 4+ years of experience to support lifecycle management, regulatory maintenance, and post-approval submissions for commercial pharmaceutical products. The role emphasizes change controls, remediation, data management in Veeva and Veeva RIM and collaboration across functions.

You will serve as regulatory liaison within cross-functional teams, coordinating with QA, manufacturing, supply chain and health authorities, driving