Regulatory Affairs Manager

Regulatory Affairs Manager

Sanofi

Reading, United Kingdom

In this role you will have responsibility for existing and new products and will involve you with working closely within a centralized team where some of the approvals occur outside of the UK. Providing optimal support to key stakeholders to delivery high quality dossiers in compliance with Health Authority requirements. Provide optimal expertise on all dossier formats, structure, navigation, and life cycle management globally. You will work in close collaboration with Quality and Process Improvement team to ensure optimal processes and tools are developed and implemented.

Key Responsibilities:

  • Manage the review, preparation, submission and follow-up of regulatory submissions to the UK and/or Irish regulatory authorities, to high standards, to ensure that marketing authorizations are obtained and maintained in line with the company’s plans and goals.
  • Develop strategic partnership with the Multi-Country Organisations (MCO) Global Business Units to understand their priorities and align regulatory objectives of the MCO regulatory team to support the business.
  • Provide strategic input into development of registration strategies for commercialization of products, both locally and in conjunction with GRA.
  • Input into review of promotional and non-promotional materials from a regulatory perspective, as required.
  • Assist the Head of Regulatory Affairs in developing strategies to optimize the efficient running of the department and to manage the achievement of appropriate registrations. Identify issues which may impact on project time frames.
  • Manage the workload and personal development of staff.
  • Supervise and train other regulatory staff within department as required by the Head of Regulatory Affairs.

About You:

To excel in this role, you will need to have:

  • A degree in science (preferably a life science), with record of proven success in achieving regulatory approvals in the UK and/or Ireland.
  • Additional experience in the pharmaceutical industry in a related field is an advantage.
  • A record of proven success in managing and supervising staff.
  • Ability to manage multi-functional projects, and to assess detailed scientific information from a variety of disciplines.
  • Good organisational skills and ability to manage multiple projects/priorities under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities.
  • Self-motivated with strong verbal and written communication skills. Able to communicate effectively and efficiently with other functional departments in the business.
  • Good knowledge of the development process for medicines, and capable of critically reviewing and integrating scientific information from a variety of disciplines.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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