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Regulatory Affairs Manager - CMC  


Posted on : 01 May 2017

Project Description

Title: Regulatory Affairs Manager  CMC IntercontinentalThe company:Amgen is one of the world s leading independent biotechnology companies, with global revenues in excess of $18 billion and over 18,000 employees. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.The role: The 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 Intercontinental region (Middle East, Turkey, Africa, Latin America and Canada).Responsibilities will include:Oversee and review the preparation of M2 and 3 CMC components of filingsAccountable for management of regional CMC filings from marketing authorisation to post-approval supplements, renewals and responses to questions across assigned products and countries.Authoring and coordinating responses to questions across assigned products and countries.Gathering, consolidating and analysing regulatory intelligence for Intercontinental region and support its application to product-specific activitiesProject management of submissions and monitoring status of applicationsEnsuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are consideredProvides guidance for regulatory assessments of change control requestsProvide regional/country, product & regulatory expertise and clarification on regional CMC RA requirementsSkills / Competencies:In-depth experience of pharmaceutical/biotechnology or medical device industryStrong record of related experience within Regulatory Affairs (min 5 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 softwareStrong team player with a commitment to customer serviceAttention to detailRelationship buildingAbility to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respectTime and project management skillsProblem solvingPrioritisationDrive for resultsProcess managementAbility to work in a fast paced environmentTechnical 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 productsBasic QualificationsBS (MS or higher preferred) life sciences, engineering or related fieldAmgen is an Equal Opportunity employer.

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