Senior Regulatory Project Manager

£65000 - £75000 per annum
  1. Permanent
Berkshire
  1. Regulatory Affairs, Operations
Posted:31/07/2020
BBBH14685

Hobson Prior currently have the opportunity for a Senior Regulatory Project Manager to join a world-wide life science organisation who are dedicated to ground-breaking scientific research and discovery.
This position will provide regulatory strategic leadership and support for our clients Oncology portfolio and will be part of the Regulatory Policy and Intelligence Network concentrating on Europe.

Job Responsibilities:

  • Responsible for producing high-quality marketing authorisation, variation and clinical trial applications in line with UK/EU requirements.
  • You will deliver pioneering regulatory strategies and promoting awareness of regulatory requirements.
  • Contributing in external EU/UK committees/working groups.
  • Managing regulatory challenges and pro-actively highlighting impact of external changes.
  • Contributing to UK / EU Regulatory Policy by assessing the external regulatory environment and communicating it to the internal organisation.
  • Supporting UK Regulatory team development by being an ambassador for the UK team.

Key Skills:

  • Strong communication skills including proven ability to influence by persuasion and negotiation.
  • Presentation skills are a key communication vehicle for networking within and outside the organisation.
  • Capability to communicate complex information in an engaging manner, both verbally and in written form.
  • Ability to thrive in and foster strong matrix team working in a global environment.
  • You are able to think strategically, sound commercial awareness and good knowledge of medicines development within EU.

Requirements:

  • You will have a bachelor's or advanced degree in appropriate scientific discipline.
  • Thorough knowledge of clinical trial requirements, particularly in major EU countries.
  • You are an experienced UK / EU regulatory professional having previously managed major submissions and approvals via the Centralised Procedure, preferably in oncology.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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