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Global CMC Compliance Leader

2 months ago

London, Greater London, United Kingdom Fraser Dove International Full time
Job Description

Job Title: Global CMC Compliance Leader

Company: Fraser Dove International

Job Type: Full-time

Location: Remote

Job Category: Compliance

About Us: Fraser Dove International is a leading executive search firm specializing in the life sciences industry. We help exceptional organizations source top talent to drive innovation and growth.

About the Role:

We are seeking a highly experienced Global CMC Compliance Leader to join our client, a leading pharmaceutical organization. As a key member of the quality team, you will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines, regulations, and approved authorizations.

Key Responsibilities:

  • 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.

What We Offer:

Fraser Dove International is committed to helping our clients find the best talent in the industry. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.