Senior Regulatory Affairs Lead

3 weeks ago


Slough, Slough, United Kingdom Blackfield Associates Full time
Company Overview
The international pharmaceutical innovation company Blackfield Associates is seeking a highly skilled Senior Regulatory Affairs professional to join their EU licensing team based in Slough.

Job Description
This permanent position involves developing and leading regulatory strategies for innovative medicinal products throughout the development, approval, and lifecycle phases. Key responsibilities include serving as the point of contact with regulatory authorities, supporting Clinical Trial Applications under the new Clinical Trials Regulation, and registering new medicinal products in the EU while maintaining existing product registrations.

Estimated Salary: £80,000 - £110,000 per annum (dependent on experience), taking into account the role's requirements and the location of Slough.

Required Skills and Qualifications
To be considered for this role, candidates must possess a degree in a relevant scientific discipline, have extensive experience with Clinical Trial Applications in the EU, and be familiar with European-wide regulatory procedures. Additionally, previous experience as a team leader or having direct reports is necessary, along with portfolio knowledge in Immunology, Oncology, Gastroenterology, or Respiratory therapeutic areas. Knowledge of Medical Device regulations is advantageous.

Benefits
This hybrid working arrangement offers a good work-life balance with flexibility and opportunities for career growth within a dynamic organization.

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