Regional Regulatory Affairs Senior Associate page is loaded Regional Regulatory Affairs Senior Associate Apply locations Portugal - Lisbon time type Full time posted on Posted Yesterday job requisition id R-186480 Career Category Regulatory Job Description 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, 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.
The ACCP will be temporarily located at the Maleo – Saldanha, Av. da República 18, 1050-191 Lisbon. We're already gearing up to have our brand-new permanent office ready in the vibrant city center of Lisbon by the spring of 2022.
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.
Regional Regulatory Affairs Senior Associate Regional Regulatory Affairs provides European regional regulatory leadership/expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.
We are a team of regulatory professionals who thrive on the challenge and opportunity that leading innovative regulatory challenges provides. Together, we in the regulatory team collaborate cross-functionally to optimally develop Amgen products, leading the regulatory authority interactions to effectively drive our product strategies.
We are seeking to hire a regulatory professional who is inspired by Amgen's science and portfolio, who can support our regulatory team and join us in our mission to serve patients.
LIVE What you will do Let's do this. Let's change the world. In this vital role you will be assigned to one or more Amgen products and may support a Regional Regulatory Lead (RRL) or lead a program under the supervision of an experienced regulatory lead.
Execute the regional regulatory strategy and regional regulatory plans. Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorizations, and lifecycle management activities. Use of Amgen systems and document management. Ensure and support regulatory product compliance . Work with Policies and SOPs. Build effective relationships and communication paths across local and functional organizations. Enable efficiencies and seamless execution across the region countries. WIN What we expect of you We are all different, yet we all use our unique contributions to serve patients. The energetic professional we seek is a collaborative and communicative person with these qualifications:
Required education:
Master's degree (scientific area) OR Bachelor's degree (scientific area) and 2 years of directly related experience. Preferred knowledge:
Degree and in-depth regulatory experience and/or related to the region. Depth knowledge of regional countries legislation and regulations relating to medicinal products. THRIVE What you can expect of us As 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, develop, and move up and across our global organization. Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act. Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth and career benefits. Flexible work arrangements. APPLY NOW for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com 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, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
. Similar Jobs (1) Senior Associate Regulatory Affairs remote type Flex Commuter / Hybrid locations Portugal - Lisbon time type Full time posted on Posted 30+ Days Ago 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.
