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Regulatory Affairs Manager

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

Job Description

Regulatory Affairs Manager required for a 12 month contract role with a leading multinational client based in Cambridge.The roleThis role will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.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 participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g. IMT, IBT, NAMT)
  • Act as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment
  • Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management
  • Under general supervision participates in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy, includes contingency regulatory planning/risk assessment
  • Region Specific Activities
  • EU: Review and approve promotional and non-promotional materials for use in the region
  • EM: Manage the product lifecycle for individual countries per national agency requirements
  • EM: Work through the regional leads to manage distributor markets
  • Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within theportfolio in compliance with global filing plans and local regulatory requirements.
  • Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
  • Provides content guidance for regional regulatory documents and meetings in accordance with GRT strategy
  • Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and pediatric plan)
  • Manages in the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
  • Under general 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
    • Requirements
  • Regulatory principles, Working with policies, procedures and SOP
  • Knowledge of relevant legislation and regulations relating to medicinal products
  • Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
  • Knowledge of drug development
  • Cultural awareness and sensitivity to achieve results across both regional country and International borders.
    • 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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