Regulatory Scientist - International Markets

£45000 - £50000 per annum
  1. Permanent
Slough, Berkshire
  1. Regulatory Affairs, Development
Posted: 23/10/2020
BBBH15297

This vacancy has now expired. Please see similar roles below...

Hobson Prior are looking for a Regulatory Scientist - International Markets for an exciting opportunity to join a leading biopharmaceutical company who purely concentrate on neurology and immunology. This position will be on a permanent basis located in Slough.

Job Responsibilities:

  • You will be accountable to support the International Markets Regulatory Science Lead and the Global Regulatory Leader for the delivery of timely approvals and up-to-date Product Information/labelling, in line with the needs identified by internal and external stakeholders, and in compliance with relevant procedures and regional/local country regulations.
  • Ensure that appropriate, up-to-date records are maintained in the Regulatory Information Management systems for compliance.
  • Lead the planning, preparation and delivery of both simple and complex submissions throughout the product's life cycle.
  • Communicate proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice and operational support
  • Recognise potential regulatory risks to the operational plan and propose options to mitigate risks.
  • Provide regulatory expertise on regulatory submissions and health authority response documents
  • Maintain awareness of competitors' activities and share potential impact these activities may have on the product development program.
  • Assist in development of regulatory standards and SOPs.

Key Skills:

  • Excellent organizational and communication skills.
  • Ability to build effective partnerships.
  • Flexibility and adaptability - Decides what to do based on the situation.
  • Results focused - ability to overcome obstacles and achieve key outcomes.

Requirements:

  • Relevant academic bachelor's degree is required.
  • At least 3-5 years hands-on experience in Regulatory Affairs, with knowledge of regulatory procedures and legislation, and focus on life cycle management for complex therapeutics.

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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