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REGULATORY AFFAIRS MANAGER postapproval

PE Global
Job LocationLondon
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

PE Global is currently recruiting for a REGULATORY AFFAIRS MANAGER (post-approval activities) for a leading multi-national Biotech client based in London.Responsibilities:

  • Lead management of MAA and provide EU support for Commercial Launch
  • Post-authorisation PIP maintenance and the submission of modifications and annual reports.
  • Lead REG planning, preparation, and submission of clinical trials
  • Support planning, preparation, and submission of MAAs as necessary
  • Provide contributions to support product life-cycle strategy.
  • Manage interactions with EMA or other regulatory authorities
  • Customarily and regularly exercise discretion and independent judgment in the performance of the duties described above.
    • Requirements:
  • Desirable to have at least five-years’ experience in Regulatory Affairs in the biotechnology industry
  • Exposure to both development and commercial phases of the product lifecycle
  • Experience with Orphan Drugs is desirable
  • Skilled at working independently and as part of a team, gathering regulatory information and developing product approval strategies
  • Preferable to have experience interacting with regulatory authorities
  • Prior experience managing regulatory submissions (e.g. CTAs, MAAs) to ensure successful in time submissions to support the strategic and operational objectives
    • Interested candidates should submit an updated CV.Please click the link below to apply, call Amparo on + or alternatively send an up to date CVAlthough it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.

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