HOW MIGHT YOU DEFY IMAGINATION?

　　THE AMGEN CAPABILITY CENTER IN LISBON, PORTUGAL (ACCP ) will be home to over 300 multi-national and multi-cultural employees, representing a broad range of cross-functional capabilities, including Commercial, General and Administrative, Information Systems, Research and Development, and more. The ACCP will offer rich career growth and development opportunities, regional and global exposure, and the opportunity to LIVE, WIN and THRIVE in one of Europe’s most attractive cities.

　　Our ACCP brand-new offices are located in Sete Rios, in the vibrant city center of Lisbon.

　　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 read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

　　International Regulatory Lead (IRL), Sr. Associate

　　Live

　　WHAT YOU WILL DO

　　International Regulatory Affairs provides regulatory leadership/ expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.

　　The International Regulatory Lead (Sr. Associate) is assigned to one or more Amgen products and may support an IRL or lead a program under the supervision of an experienced regulatory lead.

　　Execute the international regulatory strategy and regulatory plans.

　　Prepare supportive documentation for regulatory deliverables.

　　Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments).

　　Support on the local label strategy and alignment to cCDS/reference label.

　　Build effective relationships and communication paths across local and functional organizations.

　　Enable efficiencies and seamless execution across the international countries.

　　STRATEGY AND EXECUTION

　　Reviews and provides input to the international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success). If leading a program , develops the regulatory strategy documents in collaboration with another regulatory lead and communicates to others, as applicable.

　　Assists the International Regulatory Lead to support the regulatory activities (e.g. Clinical trial submissions, Marketing applications and lifecycle management filings) in compliance with global filing plans and local regulatory requirements. If leading a program , plans and manages regulatory submissions under general supervision.

　　Provides and maintains CTA/MA documentation in collaboration with the International Regulatory Lead. When appropriate, the IRL could author documents/redact documents to support a regulatory filing.

　　Assists the International Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label.

　　Performs QC of regulatory documentation (e.g. briefing packages).

　　Supports Local Regulatory teams in triaging queries from health authorities, and where appropriate, help identify existing responses to same or similar questions, leveraging knowledge management.

　　Advises and supports other groups on the review of promotional and non-promotional materials, as needed.

　　Supports process improvement initiatives and metrics.

　　Advises Global teams on regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and objectives (if leading a program) .

　　Provides regulatory direction/expertise on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, expedited regulatory designations, compassionate use and pediatric plan) (if leading a program) .

　　Manages the label submission strategy, participates in the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes (if leading a program) .

　　COMMUNICATION AND COLLABORATION

　　Participates as a member of the Global Regulatory Team (GRT), Evidence Generation Team (EGT), Labeling Working Group (LWG), Clinical Study Team (CST), Regional Brand Team and others, as applicable (if leading a program or to support the IRL) .

　　Maintains regular communications with the local teams to ensure alignment on strategy and keep the countries informed of status on the product development.

　　Partners with peers to ensure consistency in procedures.

　　Builds effective relationships and communication paths across the Global and Local elements of the GRAAS function.

　　REGULATORY RESEARCH

　　Maintains 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.

　　WIN

　　WHAT WE EXPECT OF YOU

　　Scientific and Technical

　　Knowledge of Regulatory principles.

　　Working with policies, procedures and SOP’s.

　　Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.

　　General knowledge of national legislation and regulations relating to medicinal products.

　　Understanding of drug development.

　　Others

　　Demonstrate ability to work in teams.

　　Ability to understand and communicate scientific/clinical information.

　　Education & Experience (Basic):

　　Master’s degree (scientific area) OR

　　Bachelor’s degree (scientific area) and 2 years of directly related experience

　　Education & Experience (Preferred):

　　Degree and in-depth regulatory experience and/or related to the region.

　　In-depth knowledge of regional countries legislation and regulations relating to medicinal products.

　　Thrive

　　WHAT YOU CAN EXPECT OF US

　　Vast opportunities to learn, develop, and move up and across our global organization.

　　A diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, try new things, and act.

　　Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.

　　Flexible work arrangements.

　　Equal opportunity statement

　　Amgen 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, perform essential job functions, and to receive other benefits and privileges of employment.

　　Join Us

　　If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.

　　Amgen, a biotechnology pioneer, discovers, develops, and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis, and other serious illnesses.

　　As 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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

　　Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

　　We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

　　Amgen focuses on areas of high unmet medical need and uses its 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.

　　Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

　　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.