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Regulatory Affairs Senior Manager

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

Job Description

Regulatory Affairs Senior Manager role required for a 12-month contract role with a leading multinational client based in Cambridge. The role can be remote within the UK. Responsibilities

  • Advising the GRT on regional considerations in developing strategy Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
  • May manage one or more regional leads or support roles
  • Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the clients portfolio in compliance with global filing plans and local regulatory requirements.
  • Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
  • Leads development of regional regulatory documents and meetings in accordance with GRT strategy
  • Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals , compassionate use and paediatric plan)
  • Directs the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
  • Manages regional label negotiation activities
  • With minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
  • Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
  • Co-ordinates company responses to requests from regulatory authorities, e.g Response to Questions (RTQs) Communicates regulatory strategies as appropriate such that expectations are understood.
  • Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line Management
  • Develop predictions for expectations and risks associated with outcomes by regulatory agencies
  • Ensure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments)
    • Requirements
  • At least 6 years’ experience in Regulatory Affairs within the pharmaceutical industry.
  • Experience managing marketed products through RA EMA procedures.
  • Working with policies, procedures and SOPs.
  • Understanding of the regional regulatory procedures for CTAs, PIPs, MAs, post approval changes, extensions and renewals.
  • Understanding of drug development Scientific / Technical Excellence.
  • Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes.
    • Interested candidates should submit an updated CVPlease click the link below to apply, call Alba on + or alternatively send an up to date CV***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***Although 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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