Career Category

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.

Regulatory Affairs Manager

LIVE

What you will do

Let’s do this. Let’s change the world.

The Regional Regulatory Lead (Manager) is assigned to lead one or more Amgen products. The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.

• Provide Guidance and Leadership on regional mechanisms to optimize product development and regulatory approvals.
• Develop and execute the regional regulatory strategy and regional regulatory plans.
• Ensure and support regulatory product compliance (e.g. IMR, PMCs, ESC levels, and agency commitments).
• Support and advise on the local label strategy and alignment to cCDS/reference label.
• Build effective relationships and communication paths across global, regional, local and functional organizations.
• Enable efficiencies and seamless execution across the region countries.

STRATEGY AND EXECUTION

• Advises Global/Regional teams on regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and objectives.
• Provides regulatory direction/expertise on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, expedited regulatory designations, compassionate use and pediatric plan).
• Under general supervision, plans and manages regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio and in compliance with global/regional filing plans and local regulatory requirements.
• Under general supervision, leads the development of regional regulatory strategy documents (regional regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate.
• Leads the discussions related with Agency meetings and in accordance with GRT strategy (and communicates outcomes back to GRT and others, as applicable).
• Directs the development of the regional product label by collaborating with the Labeling Working Group/Regional Review Committee to define commercial objectives in the context of available and expected scientific data, regulatory guidance, precedents and competitor labeling.
• Manages the regional label submission strategy and timelines, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes.
• Supports the approval and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs).
• Ensures/supports regulatory product compliance (e.g. IMR, PMCs, pediatric and other agency commitments).
• Reviews and approves promotional and non-promotional materials for use in the region. Advises and supports other groups on the materials data, as applicable.
   

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.
• Shares regulatory information and implications with the GRT and other Global teams on an ongoing basis and provides advice on regional considerations. Participates in LWG/ELB meetings with advice on local deviation requests.
• Partners with the regional brand team and peers to agree on product strategy including projected submission and approval time.
• 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.
• Acts as contact and create relationships with Agency staff on specific product assignment (if applicable).
   

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

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:

Doctorate degree

OR

Master’s degree and 3 years of directly related experience

OR

Bachelor’s degree and 5 years of directly related experience

Education & Experience (Preferred):

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

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.
• General awareness of the registration procedures/challenges in the region for CTAs, MAs and all lifecycle management activities.
• Knowledge and experience in the regional regulatory environment relevant for product area and development stage.
• Understanding of drug development.

Others

• Demonstrate strong team work ability.
• Good communication skills - both oral and written.
• Good negotiation and Influencing skills.
• Ability to understand and communicate scientific/clinical information.
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
• Cultural awareness and sensitivity to achieve results across both regional, country and International borders.

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.