Senior Manager - US Regulatory Affairs Lead-Oncology

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

US Regulatory Affairs Lead -Senior Manager

Live
What you will do
Let’s do this. Let’s change the world. 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 implementing regional regulatory strategies and managing effective agency interactions.

Key responsibilities include:

• To develop and implement regional regulatory strategies and manage effective agency interactions
• To recommend 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 implementation 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

Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Regulatory experience
• Or Master’s degree and 4 years of Regulatory experience
• Or Bachelor’s degree and 6 years of Regulatory experience
• High school diploma / GED and 12 years of Regulatory experience

Preferred Qualifications:

• MS, PharmD or PhD
• 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 potent