Regulatory Affairs Manager

---

Job description

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Regulatory Affairs Manager

Live

What you will do

Lets do this! Lets change the world! In this dynamic role, you will support a variety of products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), you will achieve the desired labeling by developing and implementing regional regulatory strategies and leading agency interactions.

Job tasks include but are not limited to:

• Ensure that Amgen acquires and maintains all the licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.
• Ensure regulatory compliance, with a focus on patient safety.
• Provide management and leadership to one or more leads and/or support staff.
• Implement the approved regional strategy for assigned programs.
• Advise the GRT on niche and/or geographically specific considerations in developing strategy.
• Ensure the regional needs are well defined and implemented in collaboration with relevant partners.
• Plan and lead regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
• Implementation of product-related regulatory strategies, Regulatory Affairs processes, and activity planning.
• Provide content guidance for regional regulatory documents and meetings.
• Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and pediatric plan).
• Lead the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
• Support regional label negotiation activities.
• Development, and execution of region-specific regulatory product strategies, including precedence, risk management and contingency planning.
• Support GDT on regulatory implications and requirements related to global clinical development plans and objectives
• Acquire and maintain Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs)
• Communicate regulatory strategies within team (e.g. GRT, local affiliates).
• Develop predictions for expectations and risks associated with outcomes by regulatory agencies.
• Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments).
• Ensure alignment of regional management before GRT strategy decisions.
• Partner with management and peers to ensure consistency in procedures and agency interactions.
• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
• Perform regulatory research to acquire histories, precedence and information pertinent 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 successful professional we seek is a dedicated collaborator with these qualifications.

Basic Qualifications:

• Doctorate Degree, OR
• Master's Degree & 3 years of regulatory experience, OR
• Bachelor's Degree & 5 years of regulatory experience, OR
• Associate's degree & 10 years of regulatory experience, OR
• High school diploma/GED & 12 years of regulatory experience

Preferred Qualifications:

• Knowledgeable about regulatory principles, working with regulatory submissions, interacting with regulatory agencies, and internal partners
• Awareness of the registration procedures in the region for MA, post-approval changes, extensions, and renewals
• Knowledge of national legislation and regulations relating to medicinal products
• Experience in a regional regulatory environment in a related product area and development stage
• Clinical Development experience is a plus
• Working with policies, procedures, and SOPs
• Knowledge of drug development Scientific / Technical Excellence
• Superior communication skills with the ability to understand and communicate scientific/clinical information to a broad audience
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
• Strong cultural awareness and sensitivity to the changing global environment, with the goal of achieving results across regional, country, and international borders

Thrive

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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

careers.amgen.com

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.

We will ensure that individuals with disabilities are provided 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 accommodation.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

<!– job description page –>