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Strategic Leader for Global CMC Compliance

2 months 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.

About the Role

The Head of CMC Compliance will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines, regulations, and approved authorizations.

  • Develop and implement strategic initiatives to enhance global CMC compliance and drive continuous improvement across all quality processes.
  • 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.
Requirements

The ideal candidate will have a global and service-oriented mindset with a strong sense of cultural diversity.

  • A 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 passionate and dedicated partner for exceptional life science organizations. We take pride in helping them source the talent they need to design, manufacture, and distribute life-changing drugs, treatments, and devices that transform and save patient lives.