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 within 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
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Regulatory Specialist (CMC) Commercial Lifecycle & Post-Marketing in Basel Arbeitgeber: Actalent
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