Regulatory Specialist; CMC) Commercial Lifecycle & Post-Marketing

Our client is a leading international pharmaceutical company with a strong portfolio of innovative and established products. To support ongoing lifecycle and remediation activities, we are seeking Regulatory Specialists (CMC) with experience supporting commercial products and post-approval regulatory processes.

This role focuses on lifecycle management, regulatory maintenance, change controls, remediation projects, and data management activities within the Veeva environment.

Responsibilities

• 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.

Requirements

Must Have

• 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.

Nice to Have

• Experience with in a large global pharmaceutical environment.
• Experience with biologics.
• Experience with remediation projects and legacy product data clean-up.
• Location:
  
  Basel area
• Hybrid model with minimum 50% onsite presence