Regulatory Affairs Manager

Career Category

Job Description

The International Regulatory Lead (Manager) is assigned to one or more Amgen products.

• Provide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals.
• Develops the international regulatory strategy and contributes to global regulatory plans.
• Support regulatory product compliance.
• Support on the local label strategy and alignment to cCDS/reference label.
• Build effective relationships and communication paths across global, local and functional organizations.
• Enable efficiencies and seamless execution across the international countries.
• Contribute to process improvement projects, as assigned.

STRATEGY AND EXECUTION

• Provides regulatory direction/expertise on regulatory mechanisms, regulatory risks and implications and requirements to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, expedited regulatory designations and pediatric plan).
• Reviews and provides input into international regulatory document
• Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio and contributes to the development of regulatory strategy documents (strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate.
• Provides and maintains CTA/MA documentation. May author documents/redact documents to support a regulatory filing.
• Leads internal discussions related with Agency meetings in accordance with global regulatory strategy.
• Collaborates with the global team to develop international product label and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes.

• Supports Local Regulatory teams in triaging queries from health authorities, and where appropriate, help identify existing responses to same or similar questions, leveraging knowledge management.Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance and obtains relevant histories, precedence and other information relating to Amgen products.

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) and others, as applicable
• 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.
• Ability to understand and communicate scientific/clinical information.

KNOWLEDGE & SKILLS

• Understanding of drug development and knowledge and experience in the international regulatory environment relevant for product area and development stage.
• 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 international borders.

BASIC 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 OR
• Associate’s degree and 10 years of directly related experience OR
• High school diploma / GED and 12 years of directly related experience

PREFERRED QUALIFICATIONS

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

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 and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

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, 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 essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation

Join Us

If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who

respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status

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