Amgen

Regulatory Affairs Manager, CNB

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 09, 2019
Ref
R-81440
Required Education
Bachelors Degree
Position Type
Full time
Amgen is seeking a US Regulatory Lead (USRL) to work out of our Thousand Oaks location.

The USRL will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labeling by developing and executing regional regulatory strategies and leading effective agency interactions.

The responsibilities of the USRL include:
  • To develop and execute regional regulatory strategies and lead effective agency interactions
  • To advise the GRT on regional considerations in developing strategy
  • To ensure the regional needs are well-defined and implemented in collaboration with relevant regional partners
  • To ensure that Amgen acquires and maintains all the appropriate licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products in compliance with local laws and regulations and Amgen standards
  • To ensure regulatory compliance, with a focus on patient safety
  • Represent regional regulatory affairs as a member of the GRT, Evidence Generation Team (EGT), Clinical Study Team (CST), Label Working Group (LWG), and/or Regional Teams
  • Plans and manages 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
  • Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
  • Leads development of regional regulatory documents (including labels) and meetings in accordance with GRT strategy
  • Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, expedited regulatory designations (eg, Breakthrough therapy), Fast Track, compassionate use and pediatric plan)
  • Directs 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
  • Leads regional label submission strategy and timelines, negotiation activities and deviation requests.
  • With minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
  • Consistent with GRT strategy, advise EGT on regulatory implications and requirements related to global clinical development plans and objectives
  • Share regulatory information and implications with the GRT colleagues on an ongoing basis and provide advice on regional considerations
  • Participate in LWG meetings with advice on local deviation requests
  • 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


Skills
  • Working with policies, procedures and SOP's
  • Experience with national legislation and regulations relating to medicinal products
  • Understanding of the registration procedures in region for MA, post approval changes, extensions and renewals
  • Understanding of drug development
  • Negotiation skills
  • Good interpersonal skills - both oral and written
  • Ability to understand and communicate scientific/clinical information
  • Ability to anticipate and prevent potential issues
  • Communication of regulatory strategies such that expectations are understood
  • Anticipate regulatory agency responses to strategy
  • Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
  • Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
  • Ability to resolve conflicts and develop a course of action leading to an effective outcome
  • Cultural awareness and sensitivity to achieve results across both regional country and International borders.
  • Regulatory submissions experience, experience interacting with regulatory agencies


Basic Qualifications
Doctorate degree

OR
Master's degree and 3 years of Regulatory experience
OR
Bachelor's degree and 5 years of Regulatory experience
OR
Associates degree and 10 years of Regulatory experience
Or
High school diploma / GED and 12 years of Regulatory experience

Preferred Qualifications
  • Master's degree
  • Regulatory knowledge in national regulations


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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

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.