US Regional Regulatory Lead-Oncology

Employer: Amgen
Location: Thousand Oaks, CA, US
Start date: Jul 19, 2019

Discipline: Regulatory, Regulatory Affairs, Science/R&D, Oncology
Required Education: High School or equivalent
Position Type: Full time
Hotbed: Biotech Beach, Best Places to Work

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Job Details
Company

Job Details

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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Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Company info

Website: http://careers.amgen.com/
Phone: 805-447-1000
Location: Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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