Senior Manager Regulatory Affairs

Our client, an international pharmaceutical innovation company has a requirement for a Senior Regulatory Affairs manager to join their EU licencing team.

As Regulatory Affairs Manager, you will: Develop/ Lead regulatory strategies during development, approval and lifecycle Point of contact regulatory authorities during development of innovative medicinal products/ portfolio development Support Clinical Trial Applications under the new Clinical Trials Regulation Registering new medicinal products, in the EU and to ensure that the registrations for existing marketed products are maintained.
To be considered for the role Senior Regulatory Affairs Manager role, you will: Educated to degree level in a relevant scientific discipline Extensive experience with Clinical Trial Applications in the EU Extensive experience with European wide regulatory procedures Previously lead a team/ had direct reports Portfolio knowledge in Immunology, Oncology, Gastroenterology or Respiratory therapeutic areas Knowledge of Medical Device regulations would be advantageous This is a permanent position, hybrid working with Slough based European HQ.

This role requires weekley office presence, only considering those who can reasonably commute to Slough, and applicants must hold valid right to work – no sponsorship available.