Director of Regulatory Policy Projects

2 weken geleden

Amsterdam, Noord-Holland, Nederland Planet Pharma Voltijd
The Senior Director, CMC Regulatory Affairs is responsible for managing all Chemistry, Manufacturing, and Controls (CMC) regulatory affairs activities for product candidates, from the transition from Research to Development through to product licensure.

This role would involve occasional travel to the client site in the Netherlands - biweekly

This role requires significant expertise in regulatory affairs for biologics and/or bio-pharmaceuticals, with a deep understanding of global regulatory frameworks (EU/US), GMP, GLP, GCP, GDP, and GRP. The Senior Director will work cross-functionally to ensure seamless integration of CMC regulatory strategies into development programs, enabling the timely progression of clinical trials and product development.

Oversee CMC Regulatory Affairs Strategy: Jointly develop and implement CMC regulatory strategies for product candidates, including strategies for IND/CTA/MAA/BLA submissions, clinical trial design, and regulatory interactions.
Management and Coordination of CMC Regulatory Activities: Oversee and coordinate all internal and external CMC regulatory activities related to product candidates, including activities with external partners and contractors, and those in co-development or partnership.
Contractor Selection and Performance Monitoring: Lead the selection, evaluation, and monitoring of contractors for CMC regulatory affairs activities. Ensure contractors meet quality and performance standards, managing relationships to ensure timelines and deliverables are met.
Defining CMC Regulatory Affairs Strategy: Jointly develop the CMC regulatory strategies for product candidates, including strategies for IND/CTA/MAA/BLA submissions, clinical trial design, and regulatory interactions.
Regulatory Affairs Department Creation: Work in cooperation with Clinical Regulatory Affairs to establish and support a regulatory affairs department.
Approval of CMC Regulatory Affairs Contractors: Support the approval process for contractors and vendors involved in CMC regulatory activities.
Regularly report on the status and planning of CMC regulatory affairs dossiers and submissions to internal stakeholders, ensuring proactive communication of timelines, milestones, and potential risks.
Manage and Coach: Lead and mentor the CMC-RA team, which consists of 3 team members, working collaboratively to achieve goals.
Conflict Management and Escalation: Ensure any conflicts between external contractors/vendors related to CMC regulatory affairs are identified, addressed, and escalated as necessary to ensure timely resolution and project success.

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