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Regulatory Affairs Senior Manager CMC Europe

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

Job Description

Regulatory Affairs Senior Manager required for an 11-month contract role with a leading multinational client based in Uxbridge. Remote work within the UK.The roleThe Regulatory Professional will play a key role in developing and executing CMC regulatory strategies for new marketing authorisation applications and throughout whole product lifecycle for the European and extended European region.Reponsibilities

  • Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
  • Oversee and review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
  • Manages Strategy and Execution for all regulatory submissions (e.g. clinical trial, variations, extensions and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
  • Leads development of regional regulatory documents (briefing books) and meetings in accordance with global regulatory strategy
  • Authoring and coordinating responses to questions across assigned products and countries.
  • Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and pediatric plan)
  • Gathering, consolidating and analysing regulatory intelligence for the EU region and support its application to product-specific activities
  • CMC RA subject matter expertise for a group of countries within the EU region
  • Project management of submissions and monitoring status of applications
  • Ensuring the regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders
  • Ensure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments)
  • Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations
  • Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to products.
  • Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
  • Document and communicate details and outcomes of regulatory agency interactions to global regulatory and operations teams and relevant sr. management
    • Requirements
  • Regulatory knowledge in regional legislation
  • Working with policies, procedures and SOPs
  • Experience with national legislation and regulations relating to medicinal products
  • Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
  • Understanding of drug development Scientific / Technical Excellence
  • Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
  • In-depth experience of pharmaceutical/biotechnology or medical device industry
  • Strong record of related experience within Regulatory Affairs (min 7 years)
  • CMC- specific regulatory knowledge & experience within biotechnology
  • Direct experience with EU and EM market applications – MAAs or variations
  • Good understanding and direct experience of ex US filings
  • Creation and execution of regional regulatory strategies – MAAs or variations
  • Current knowledge and application of CMC hot topics and knowledge of EU/EM legislation and guidance for biotechnology products
    • 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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