Regulatory Affairs Strategy Leader

1 day ago


Slough, Slough, United Kingdom Blackfield Associates Full time

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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