Head of Global CMC Compliance

4 weeks ago

London, Greater London, United Kingdom Fraser Dove International Full time
Head of CMC Compliance Opportunity

Fraser Dove International is partnering with a leading pharmaceutical organization to find a strategic leader to oversee Global CMC Compliance. As the Head of CMC Compliance, you will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines, regulations, and approved authorizations.

Key Objectives:
  • Develop and implement strategic initiatives to enhance global CMC compliance and drive continuous improvement across all quality processes.
  • Ensure regulatory compliance for all medicinal products and medical devices, in line with guidelines, regulations, and approved authorizations.
  • Manage the change control process and ensure timely and efficient creation of regulatory documentation for dossiers.
  • Determine CMC-regulatory strategy and ensure QA oversight over due diligence and post-merger integrations.
  • Recruit, coach, and develop the Global CMC Compliance team, while managing resources and supporting career development.
  • Plan and monitor the budget for Global CMC Compliance.
  • Support cross-departmental projects focused on operational excellence and business development.
  • Assist the Head of Global Quality Assurance with strategic definition and planning, as well as leading special projects.
Requirements:
  • A global and service-oriented mindset with a strong sense of cultural diversity.
  • The ability to prioritize and manage multiple complex projects, ensuring critical deadlines are met.
  • University degree, preferably in Pharmacy, with several years of experience in Quality Assurance, Regulatory Compliance, and/or Regulatory Affairs in pharmaceutical companies.
  • Profound knowledge of CMC dossiers, regulatory requirements, and quality documentation for medicinal products.
  • Fluent in German and English.

Fraser Dove International is a leading executive search firm specializing in life sciences. We take pride in helping exceptional organizations source the talent they need to design, manufacture, and distribute life-changing drugs, treatments, and devices that transform and save patient lives.

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