Amgen US Regional Regulatory Lead-Oncology in Thousand Oaks, California

Amgen is seeking a US Regional Regulatory Lead to work out of our Thousand Oaks location.

The US Regional Regulatory Lead 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 managing effective agency interactions.

The responsibilities of the US Regional Regulatory Lead include:

  • To develop and execute regional regulatory strategies and manage 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 stakeholders

  • To ensure that Amgen acquires and maintains all the required 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

  • Manages 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

Basic Qualifications:

Doctorate degree and 2 years of Regulatory experience

OR

Master's degree and 6 years of Regulatory experience

OR

Bachelor's degree and 8 years of Regulatory experience

OR

Associate's degree and 10 years of Regulatory experience

OR

High school diploma / GED and 12 years of Regulatory experience

Preferred Qualifications:

  • MS Degree

  • Contemporary Oncology Regulatory experience

  • Regulatory knowledge in national regulations

  • 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 communication 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 a beneficial outcome

  • Cultural awareness and sensitivity to achieve results across both regional country and International borders.

  • Regulatory submissions experience, experience interacting with regulatory agencies

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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.