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Job Description

Global Regulatory Operations – Regulatory Data & Analytics – Senior Associate

Job Description:

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.

Global Regulatory Operations provides a team of regulatory professionals who thrive on the challenge and opportunity that they are part of everyday and are excited to monitor, analyze and produce data that will help support a regulatory strategic decision.  We in the regulatory operations team collaborate cross-functionally to optimally develop Amgen products. 

We are seeking to hire a regulatory operations 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.  More specifically, we are looking for a regulatory professional who has experience in:

• Updating the Regulatory Submissions and Document Information Management System (RSDIMS)
• Working with, monitoring, and updating the Pharmaceutical Regulatory Submission and Document Information Management System (RIDMS)
• Monitoring data quality/health, including collaboration with other internal functions
• Metrics compilation and analysis
• Liaising with internal customers to improve efficiencies within Regulatory Data Analytics and other functional areas
• Managing requests within the Regulatory Intake System to comply with data management of a GMP system

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 will cross functionally support various teams with:

• Maintaining Regulatory documents and tracking submissions
• Creating/archiving Clinical Trial and Marketing Application submissions and Health Authority correspondence
• Being the point of contact between Regulatory Representatives/CMC and publishing teams.
• Ensuring Regulatory compliance with SOPs and Regulatory authorities
• Providing training, mentoring and support to RDA team members and other functional areas, including vendors.
• Collaborating with external partners/outsourced CROs

To do this you will:

• Use Amgen document management systems.
• Ensure and support regulatory submissions
• Work with guidance documents and SOPs.
• Build effective relationships and communication paths across local and functional organizations.
• Enable efficiencies and seamless execution across the region countries

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:

• Working in teams
• Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
• Strong proven understanding of the Veeva Vault system
• Good written and verbal communication skills
• Detail oriented with critical thinking skills
• Independent time management and prioritization skills
• Work efficiently with little support and minimal to no supervision

Education & Experience (Basic):

• Bachelor’s degree and 2 years of directly related experience
• Master’s degree
• Associate’s degree and 6 years of directly related experience

Education & Experience (Preferred)

• Industry experience
• Experience in an operationally-focused role within Regulatory Affairs

What you can expect of us

As we work to develop treatments that take care of others, we also work to care of our teammates’ professional and personal growth and well-being.  At Amgen there are:

• 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.