Regulatory Affairs Sr. Manager, International CMC in Hillingdon - Amgen

Job Overview

Hillingdon, England
Job Type
Full Time
Date Posted
8 days ago

Additional Details

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Job Description

Career CategoryRegulatoryJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.REGULATORY AFFAIRS SENIOR MANAGER – INTERNATIONAL CMCLIVEWhat you will doIn this vital role you will be responsible for developing and executing CMC regulatory strategies for new Marketing Authorization Applications, Clinical Trial Applications, and Post-approval Variations dossiers that comply with International country/region regulatory standards.  You will work in close collaboration with the Center Director for International Regulatory CMC, International CMC leads as well as country local Regulatory representatives on ensuring efficient execution of the regional submission plans.Key responsibilities include:Responsibility for the generation and execution of international country specific regulatory strategiesAccountable for management of regional CMC filings from marketing authorisation to post-approval supplements, renewals and responses to questions across assigned products and countries for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision. Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are consideredReview and preparation  of M2 and 3 components for International Clinical Trial Applications, Marketing Applications and post-market supplements/variationsAuthoring and coordinating responses to questions across assigned products and countries.Gathering, consolidating and analysing regulatory intelligence for International Markets and supports its application to product-specific activitiesProject management of submissions and monitoring status of applicationsProvides guidance for and performs regulatory assessments of change control requestsProvide regional/country, product & regulatory expertise and clarification on International CMC RA requirementsBe part of our teamYou would be joining the International Regulatory CMC Center, a global team which operates from Uxbridge and Cambridge in the UK; as well as US based sites.  The team is part of the Global Regulatory CMC organization that supports Amgen’s diverse portfolio of investigational and commercially approved products around the world.  The International CMC team in collaboration with our local regulatory affiliates is responsible for developing CMC product strategy and the execution and delivery of regulatory submissions in International Markets..WINWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced  professional, are these qualifications and skills:Master’s or Bachelor’s degree or equivalentRegulatory Affairs experienceCreation and execution of regional regulatory strategiesCMC specific regulatory knowledge and experience or in the manufacture/testing of pharmaceutical productsDirect experience with International market applications – MAAs or variationsGood understanding of the direct experience of ex US filingsExcellent communication skills with ability to communicate across all levelsProject management skills with ability to work well with others in demanding situationsAbility to work in a fast-paced environmentCurrent knowledge and application of CMC hot topics and knowledge of International legislation and guidance for biotechnology productsStrong MS Office skillsTHRIVEWhat you can expect of usAs we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.Vast opportunities to learn and move up and across our global organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsLOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.APPLY NOWfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation..SummaryLocation: United Kingdom - Cambridge; United Kingdom - UxbridgeType: Full time


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