Michael Page

Regulatory Affairs Manager - UK & IE

Location
England, London / England
Salary
Negotiable
Posted
23 Apr 2021
Closes
21 May 2021
Ref
JN -032021-2370671
Contact
Chloe Baverstock
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Exciting opportunity to join a global well known pharmaceutical business who have ambitious growth plans and due to expansion are looking for a Regulatory Affairs Manager to join the team.

Client Details

I have partnered with one of the large global pharmaceutical businesses known all across the world. They have some exciting and ambitious growth plans over the next 5 years.

My client is extremely well known in the industry and due to expansion are looking for a Regulatory Affairs Manager to join the team.

Description

Regulatory Affairs Manager

  • Manage the review, preparation, submission and follow-up of regulatory submissions to the UK and Ireland.
  • Provide strategic input into development of lifecycle strategies for Marketed Portfolio & Strategy Management 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 optimise the efficient running of the department and to manage the achievement of appropriate registrations. Identify issues which may impact on project timeframes.
  • Manage the workload and personal development of staff.
  • Supervise and train other regulatory staff within department as required.

Profile

Regulatory Affairs Manager

  • A scientific degree.
  • Proven success record of achieving regulatory approvals in the UK
  • 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.
  • 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.
  • An understanding of biosimilars and medical devices.

Job Offer

Competitive Basic Salary + Car Allowance + Bonus

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