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Regulatory Affairs Manger EU CMC United Kingdom,  

Posted on : 01 May 2017

Project Description

Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategiesReview the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countriesManages Strategy and Execution for all regulatory submissions (e.g. clinical trial, variations, extensions and marketing applications) for products within Amgen'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 activitiesPoint of Contact with local country regulatory staffProject management of submissions and monitoring status of applicationsCommunicate 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 considerationsMaintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen 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 requestsSets project timeframes and priorities for products under their responsibility based on project objectives and ongoing assignments; raises resource constraintsDocument 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 legislationWorking with policies, procedures and SOPs Experience with national legislation and regulations relating to medicinal productsUnderstanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals. Understanding of drug development Scientific / Technical ExcellenceStrong 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 serviceIn-depth experience of pharmaceutical/biotechnology or medical device industryStrong record of related experience within Regulatory Affairs (min 7 years)Strong communication skills - oral and written Organizational skillsStrong interpersonal skillsAbility to develop solutions to technical and organizational issues in order to improve performance and productivityStrong computer skills, including word processing, database document repository and project management software Attention to detailRelationship buildingAbility to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respectTime and project management skillsProblem solvingPrioritisationAbility to work in a fast paced environment Technical SkillsCMC- specific regulatory knowledge & experience within biotechnologyDirect experience with EU and EM market applications  MAAs or variationsGood understanding and direct experience of ex US filingsCreation and execution of regional regulatory strategies  MAAs or variationsManagement of intelligenceExpanding knowledge of related disciplinary areasUnderstands the core business process and purpose of the functional area in Amgen s commercialization processDeveloping own project management techniquesEnhances own knowledge through understanding business trends and objectivesCurrent knowledge and application of CMC hot topics and knowledge of EU/EM legislation and guidance for biotechnology productsSubstantial related experience within Regulatory Affairs


United Kingdom Uxbridge; United Kingdom Cambridgeshire

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