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Regulatory Affairs Manger EU CMC United Kingdom,  

Amgen (company)


Posted on : 01 May 2017

Project Description

Description:
  • Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
  • 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 company's portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision. 
  • Inputs into the 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 input 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
  • Point of Contact with local country regulatory staff
  • Project management of submissions and monitoring status of applications
  • Communicate 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, pediatric 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 company products. 
  • Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. 
  • Provides guidance for regulatory assessments of change control requests
  • Sets project timeframes and priorities for products under their responsibility based on project objectives and ongoing assignments; raises resource constraints
  • Document and communicate details and outcomes of regulatory agency interactions to global regulatory and operations teams and relevant sr. management 



Knowledge and Skills 
  • 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 
  • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome 
  • Cultural awareness and sensitivity to achieve results across both regional country and International borders.
  • Strong team player with a commitment to customer service
  • In-depth experience of pharmaceutical/biotechnology or medical device industry
  • Strong record of related experience within Regulatory Affairs (min 7 years)
  • Strong communication skills - oral and written Organizational skills
  • Strong interpersonal skills
  • Ability to develop solutions to technical and organizational issues in order to improve performance and productivity
  • Strong computer skills, including word processing, database document repository and project management software Attention to detail
  • Relationship building
  • Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
  • Time and project management skills
  • Problem solving
  • Prioritisation
  • Ability to work in a fast paced environment



Technical Skills
  • 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
  • Management of intelligence
  • Expanding knowledge of related disciplinary areas
  • Understands the core business process and purpose of the functional area in company's commercialization process
  • Developing own project management techniques
  • Enhances own knowledge through understanding business trends and objectives
  • Current knowledge and application of CMC hot topics and knowledge of EU/EM legislation and guidance for biotechnology products
  • Substantial related experience within Regulatory Affairs

Locations

United Kingdom Uxbridge; United Kingdom Cambridgeshire

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