Regulatory Affairs Manager page is loaded Regulatory Affairs Manager Apply locations Portugal - Lisbon time type Full time posted on Posted 12 Days Ago job requisition id R-186479 Career Category Regulatory Job Description HOW 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 MANAGERLIVEWhat you will doIn this vital role you will work to ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.You will support one or more products from a regional regulatory perspective.Strategy and ExecutionPlan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.Provide content guidance for regional regulatory documents and meetings in accordance with global strategyProvide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)Support regional label negotiation activitiesUnder general supervision participate in the development, and execution of regional regulatory product strategiesUnder general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agenciesRegulatory ResearchMaintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.Under supervision evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labellingBe part of our teamYou will be joining the European General Medicine Regulatory team, part of the Global Regulatory Affairs function in Europe. You will be working with colleagues who are responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the products lifecycle.This team leads the regulatory activities for established products and also development assets in the Metabolic, Cardiology, Inflamation, Endocrine and Bone disease areas, as well as pre-approval filing activities for Biosimilars.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:Scientific Degree and demonstrated experience in a similar roleRegulatory principles Working with policies, procedures and SOP'sKnowledge of legislation and regulations relating to medicinal productsAwareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals.Knowledge of drug developmentKnowledge of and experience in regional regulatory environmentStrong communication skills - both oral and writtenAbility to understand and communicate scientific/clinical informationAbility to anticipate and prevent potential issuesAbility to resolve conflicts and develop a course of action leading to a beneficial outcomeTHRIVEWhat 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.Growth 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: Flexibility to work from home with few days per month working from our office in Lisbon.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 us.careers.amgen.comAmgen 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..About Us Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.#J-18808-Ljbffr
