Regulatory Affairs Manager- US Regulatory Lead

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Regulatory Affairs Manager- US Regulatory Lead

What you will do

Let’s do this. Let’s change the world. In this vital role, you will support a variety of products from a US regulatory perspective. As a member of the Global Regulatory Team (GRT), you will achieve the desired labeling by developing and implementing regional regulatory strategies and leading agency interactions.

Responsibilities include:

• 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 to one or more leads and/or support staff.
• Implement the approved regional strategy for assigned programs.
• Advise the GRT on niche and/or geographically specific considerations in developing strategy.
• Ensure the regional needs are well defined and implemented in collaboration with relevant partners.
• Plan and lead US 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.
• Implementation of product-related regulatory strategies, Regulatory Affairs processes, and activity planning.
• Provide content guidance for US regulatory documents and meetings.
• Provide regulatory guidance on US regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and pediatric plan).
• Lead the development of the US 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 US label negotiation activities.
• Development, and execution of region-specific regulatory product strategies, including precedence, risk management and contingency planning.
• Support GRT on regulatory implications and requirements related to global clinical development plans and objectives
• Acquire and maintain IND and Marketing Application approvals including Response to Questions (RTQs)
• Communicate regulatory strategies within team (e.g. GRT, local affiliates).
• Develop predictions for expectations and risks associated with outcomes by regulatory agencies.
• Ensure regulatory product compliance for product (e.g. pediatric and other agency commitments).
• Ensure alignment and support for 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 dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate Degree

Or

Master's Degree and 2 years of regulatory experience

Or

Bachelor's Degree and 4 years of regulatory experience

Or

Associate's degree and 8 years of regulatory experience

Or

High school diploma/GED and 10 years of regulatory experience

Preferred Qualifications:

• Knowledgeable about regulatory principles, working with regulatory submissions, interacting with regulatory agencies, and internal partners
• Awareness of the registration procedures in the region for MA, post-approval changes, extensions, and renewals
• Knowledge of nation