Job Description

Career Category RegulatoryJoin Amgenxe2x80x99s Mission of Serving PatientsAt Amgen, if you feel like youxe2x80x99re part of something bigger, itxe2x80x99s because you are. Our shared missionxe2x80x94to serve patients living with serious illnessesxe2x80x94drives all that we do.Since 1980, wexe2x80x99ve helped pioneer the world of biotech in our fight against the worldxe2x80x99s toughest diseases. With our focus on four therapeutic areas xe2x80x93Oncology, Inflammation, General Medicine, and Rare Diseasexe2x80x93 we reach millions of patients each year. As a member of the Amgen team, youxe2x80x99ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youxe2x80x99ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.What you will doLetxe2x80x99s do this. Letxe2x80x99s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgenxe2x80x99s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level.Additional job responsibilities include:Lead submission for annual reports, facility registrations, facility renewals, and product renewalsPotential to oversee or manage staffAct as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teamsInteract with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissionsPreparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notificationsCoordination, preparation, collection and/or legalization of CMC country specific documentsDocument and archive CMC submissions and related communications in the document management systemInitiate and maintain CMC product timelines at the direction of product leadInterface with the regulatory operations teamTrain staff on select CMC procedures and systemsProvide report status of activities and projects to teams and departmentParticipate in cross-functional special project teamsWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients.Basic Qualifications:Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryORMasterxe2x80x99s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry ORBachelorxe2x80x99s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryPreferred Qualifications:Experience managing or overing staff membersExperience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical developmentRegulatory CMC specific knowledge and experienceMature project management and organizational skillsStrong and effective oral and written communication skillsExperience in Veeva Vault platformsWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, wexe2x80x99ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided 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 accommodation..

Amgen