Regional Regulatory Affairs Senior Associate Lisboa

Regional Regulatory Affairs Senior Associate
Lisboa
Lisboa, Lisboa, Portugal

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Regional Regulatory Affairs Senior Associate

Apply remote type Flex Commuter / Hybrid locations Portugal - Lisbon time type Full time posted on Posted Yesterday job requisition id R-209491

Career Category

Regulatory

Job Description

Join our team at AMGEN Capability Center Portugal, number 1 company in Best Workplaces - Great Place to Work Institute ranking in Portugal (category 201-500 employees). We have a growing team of 380 talented people and more than 38 different nationalities, diverse areas of expertise and professional experience that are shaping the future of healthcare. This is your chance to explore a world of opportunities in different areas such as Cybersecurity, Data & Analytics, Digital, Technology and Innovation, Finance, General & Admin, Human Resources, Regulatory Affairs and many more. Based in Lisbon's city center, our AMGEN office fosters innovation, excellence, and inspiration. Come thrive with us at AMGEN, supporting our mission To Serve Patients.

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
- 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.

WHAT YOU WILL DO

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.

1. Execute the regional regulatory strategy and regional regulatory plans.
2. Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorizations, and lifecycle management activities.
3. Use of Amgen systems and document management.
4. Ensure and support regulatory product compliance.
5. Work with Policies and SOPs.
6. Build effective relationships and communication paths across local and functional organizations.
7. Enable efficiencies and seamless execution across the region countries.

WHAT WE EXPECT OF YOU

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
  - depth regulatory experience and/or related to the region.
• Depth knowledge of regional countries legislation and regulations relating to medicinal products.

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, take risks, and act.
• Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
• Flexible work arrangements.

APPLY NOW

Objects in your future are closer than they appear. Join us.

EQUAL OPPORTUNITY STATEMENT

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 a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

About Us

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.