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Chief Compliance Officer
2 months ago
Job Title: Chief Compliance Officer - Global Regulatory Expert
Job Summary:
Fraser Dove International is seeking a highly experienced and skilled Chief Compliance Officer to lead our client's Global CMC Compliance function. As a key member of the leadership team, you will be responsible for ensuring regulatory compliance across all medicinal products and medical devices, developing and implementing strategic initiatives to enhance global CMC compliance, and driving continuous improvement across all quality processes.
Key Responsibilities:
- Ensure regulatory compliance for all medicinal products and medical devices, in line with 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.
- 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.