Director CMC Regulatory Affairs

4 weken geleden

netherlands netherlands Planet Pharma Voltijd

Job Overview:

The Senior Director, CMC Regulatory Affairs will be responsible for managing all Chemistry, Manufacturing, and Controls (CMC) regulatory affairs activities for product candidates, starting from the transition from Research to Development and continuing through product licensure. This leadership role ensures the development and implementation of CMC regulatory strategies, timely and compliant regulatory submissions, and coordination of both internal and external CMC regulatory activities, including those related to co-development partnerships.


Key Responsibilities:

  1. Preparation, Review, and Approval of CMC Regulatory Filings:
  • Lead the preparation and regulatory submission of CMC sections for regulatory filings such as IMPD/IND/MAA/BLA.
  • Ensure all submissions are accurate, compliant, and submitted on time.
  1. CMC Regulatory Affairs Strategy Oversight:
  • Jointly develop and implement CMC regulatory strategies for product candidates.
  • Oversee strategies for IND/CTA/MAA/BLA submissions, clinical trial design, and regulatory interactions.
  1. Management and Coordination of CMC Regulatory Activities:
  • Lead and coordinate all internal and external CMC regulatory activities related to product candidates, including those with external partners, contractors, and co-development partnerships.
  1. 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 meet timelines and deliverables.


Areas of Support:

  1. Defining CMC Regulatory Affairs Strategy:
  • Jointly develop the CMC regulatory strategies for product candidates, including IND/CTA/MAA/BLA submissions, clinical trial design, and regulatory interactions.
  1. Regulatory Affairs Department Creation:
  • Collaborate with Clinical Regulatory Affairs to establish and support a regulatory affairs department.
  1. Approval of CMC Regulatory Affairs Contractors:
  • Support the approval process for contractors and vendors involved in CMC regulatory activities.

Key Activities:

  1. Status and Planning Reporting:
  • Regularly report on the status and planning of CMC regulatory affairs dossiers and submissions to internal stakeholders.
  • Ensure proactive communication of timelines, milestones, and potential risks.
  1. Team Leadership and Coaching:
  • Lead and mentor the CMC-Regulatory Affairs team, consisting of 3 team members, ensuring collaborative achievement of goals.
  1. Conflict Management and Escalation:
  • Identify, address, and escalate any conflicts between the organization and external contractors/vendors related to CMC regulatory affairs to ensure timely resolution and project success.


Required Qualifications:

  • Extensive expertise in regulatory affairs for biologics and/or bio-pharmaceuticals.
  • In-depth knowledge of global regulatory frameworks (EU/US), GMP, GLP, GCP, GDP, and GRP.
  • Proven experience in managing CMC regulatory strategies and ensuring timely submissions.
  • Strong cross-functional collaboration skills to integrate CMC strategies into development programs.
  • Experience in team leadership and mentoring.
  • Strong communication, conflict resolution, and stakeholder management skills.


Preferred Qualifications:

  • Prior experience working in co-development partnerships or with external contractors/vendors.
  • Knowledge of CMC regulatory activities for biologics at various stages of development.

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