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Job Location | Cambridge |
Education | Not Mentioned |
Salary | Salary negotiable |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent , full-time |
Exciting and unique opportunity to join my client at a very important period of growth as Head Of Global Regulatory Affairs.Client DetailsMy client are a fast growing innovative and exciting pharmaceutical business who focus on rare metabolic and neurological genetic conditions. We are looking for a Head Of Global Regulatory Affairs to be based out of the Cambridge office.DescriptionHead Of Global Regulatory AffairsYou will provide leadership and management to the regulatory, clinical, labelling and PV teams, and take responsibility for the registration and maintenance of licences for pharmaceutical products, pharmacovigilance activities and clinical activities globally.You will provide regulatory, clinical, labelling and PV advice to the wider team in respect of current assets and attend internal and external stakeholders meetings as part of the leadership team. The role will be responsible for the development of the teamas a group and for the individuals through mentoring, coaching and acting as a role model.Provide leadership and regulatory support to ensure the development of a team that delivers:* Up-to-date regulatory expertise on marketing authorisations requirements and procedures to develop faster to market product development and approval strategies with optimal labelling that support the commercial goals.* Provides a key interface with global regulatory agencies and external partners.* Define strategies for life cycle management, maintenance and compliance of existing marketed assets.* Maintain a pharmacovigilance and labelling systems that support existing and new assets* Ensure regulatory strategies for registration and life cycle maintenance of product licences are delivered on-time and in accordance to agreed budget.* Manage CRO (clinical, regulatory, pharmacovigilance) and partner relationships where regulatory interaction is required.ProfileHead Of Global Regulatory Affairs