Regulatory Affairs Manager - Regional Regulatory Lead

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 Regional Regulatory Lead

Live

What you will do

Lets do this. Lets change the world. In this vital role you will achieve the desired labeling by developing and executing US regulatory strategies.

Responsibilities:

• Execute the US regulatory plan and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the US
• Provide content for and coordinate US regulatory documents and meetings in accordance with GRT strategy (eg, responses to regulatory agency questions)
• Develop US regulatory strategies
• Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line management
• Develop regulatory risks and predictions of interactions with regulatory agencies
• Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments)
• Provide regulatory guidance on US regulatory mechanisms to optimize product development (e.g. orphan drug, fast track, early access, pediatric plan)
• Exchange regulatory information with GRT and cross-functional colleagues on an ongoing basis and provide advice on regional considerations
• Communicate and ensure alignment of regional management before GRT strategy decisions
• Partner with regional 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 relevant histories, precedence and other information relevant to product advancement in the US
• Under supervision evaluate and communicate impact of relevant US regulations, guidances, current regulatory environment, and competitor labeling
• With general supervision, serve as point of contact and develop relationships with points of contact at the FDA on specific product assignment
• Document and communicate details and outcomes of FDA interactions to GRT and relevant Sr. management
• Under general supervision, participate in core regulatory activities to ensure effective FDA interactions consistent with the Global Regulatory strategyincludes contingency regulatory planning/risk assessment
• Manage the development of the US product label by collaborating with the Labeling Working Group in the context of available and expected scientific data, regulatory guidance and precedent, support label negotiations
• Advise and support promotion group regarding applicability of data for product communication in the US
• Keep regulatory intelligence tool(s) current

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications.

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 3 years of experience in regulatory or pharmaceutical drug development Or
• Bachelors degree and 5 years of experience in regulatory or pharmaceutical drug development Or
• Associates degree and 10 years of experience in regulatory or pharmaceutical drug development Or
• High school diploma / GED and 12 years of experience in regulatory or pharmaceutical drug development

Preferred Qualifications:

• Regulatory submissions experience (eg, INDs or CTAs)
• Experience interacting with regulatory agencies
• Knowledge of regulatory principles
• Working with policies, procedures, and SOPs
• Knowledge of national legislation and regulations relating to medicinal products
• Awareness of the registration procedures in region for MA, post approval changes, extensions, and renewals
• Knowledge of drug development
• Teamwork
• Communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Knowledge of and experience in regional regulatory environment in relevant product area and development stage
• Understanding of regulatory activities and their touch points
• 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

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.