Regulatory Affairs Manager
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 ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), the Manager will achieve the desired labeling by developing and executing regional regulatory strategies and leading agency interactions.
- 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 by supervising one or more other regional regulatory leads and/or support staff.
- Execute the approved regional strategy for assigned programs.
- Advise the GRT on regional considerations in developing strategy.
- Ensure the regional needs are well defined and implemented in collaboration with relevant regional 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.
- Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Provide content guidance for regional regulatory documents and meetings in accordance with GRT strategy.
- 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).
- Manage 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.
- Under general supervision participate in the development, and execution of regional regulatory product strategies, including precedence, risk management and contingency planning.
- Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
- Obtain and maintain Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs)
- Communicate regulatory strategies within team (e.g. GRT, local affiliates).
- Under general supervision, 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).
- Communicate and 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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a 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
- Regulatory submissions experience
- Experience interacting with regulatory agencies
- Clinical Development experience
- Cross-functional experience Knowledge and Skills
- 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 Scientific / Technical Excellence
- Communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and prevent potential issues
- 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
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual 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 UsIf 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.