Senior Manager Regulatory Affairs- London- up to £75,000 per annum

Accenian are excited to be working on a new opportunity for a Regulatory Affairs Senior Manager at a speciality pharmaceutical company based in London.

You will coordinate all regulatory activities and provide oversight in regulatory compliance of drug product design. The company has a developing pipeline, including a range of drug-device combination products.

Key Roles & Responsibilities:

  • Provide regulatory expertise and leadership.
  • Lead all aspects of regulatory for drug-device combination product development from early stage clinical through to commercialisation.
  • Interpret regulatory policies and guidance.
  • Prepare and review regulatory submission documents- marketing authorisation, devices and CTA’s.
  • Provide assistance and guidance to third-party contractors in developing drug-device combination products.
  • Interface with global regulatory authorities and notified bodies.
  • Develops and maintains strong working knowledge of regulatory guidelines.
  • Build and maintain effective relationships with external stakeholders.

Job Requirements:

  • Significant regulatory affairs experience within US and EU regulations and procedures.
  • In-depth working knowledge of FDA regulations on drug-device combination products.
  • Working knowledge of the EU medical device submission requirements and the EU medical device regulation.
  • Bachelor’s degree equivalent or higher qualification within Pharmaceutical or relevant life science
  • Ability to multitask and manage multiple deadlines
  • Work well independently.

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