Regional Regulatory Affairs Senior Associate

Amgen Inc.

3.6

(9)

Lisbon, Portugal

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-186480

    Position summary

    d 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.

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging