Regulatory Affairs Strategy Leader
1 day ago
Company Overview
Blackfield Associates is a leading international pharmaceutical innovation company with a presence in the EU. We are seeking an experienced Senior Regulatory Affairs Manager to join our EU licensing team.
About the Role
We offer a competitive salary of £80,000 - £110,000 per annum, depending on experience, and a comprehensive benefits package, including hybrid working options and opportunities for career growth.
Job Description
- Develop and lead regulatory strategies during development, approval, and lifecycle management of innovative medicinal products.
- Serve as the primary point of contact with regulatory authorities during the development of new medicinal products and portfolio development.
- Support Clinical Trial Applications under the new Clinical Trials Regulation.
- Register new medicinal products in the EU and ensure the maintenance of existing marketed product registrations.
Required Skills and Qualifications
- Educated to degree level in a relevant scientific discipline (e.g., chemistry, biology, or pharmacy).
- Extensive experience with Clinical Trial Applications in the EU.
- Experience with European-wide regulatory procedures.
- Previous leadership experience, including managing teams and direct reports.
- Familiarity with therapeutic areas such as Immunology, Oncology, Gastroenterology, or Respiratory.
- Knowledge of Medical Device regulations is advantageous.
Benefits
We offer a dynamic work environment, opportunities for professional growth, and a competitive salary. If you are passionate about regulatory affairs and have a strong background in the industry, we encourage you to apply.
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