Global Regulatory Affairs Director - Inflammation and Rare Disease

Job Title: Global Regulatory Affairs Director - Inflammation and Rare Disease

Job Location: Washington D.C., District of Columbia, United States

Job Location Type: Remote

Job Contract Type: Full time
Job Seniority Level:
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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 Director - Inflammation and Rare Disease
What you will do

Let’s do this. Let’s change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Inflammation and Rare Disease Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.

In this vital, product-facing role you will lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The role of the Regulatory Affairs Director is to lead GRTs within Amgen’s GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions, and to provide regulatory expertise and guidance to product teams.
Key Responsibilities:

- Develop and execute the global regulatory product strategy

- Lead GRTs

- Represent Regulatory on the product team and other key commercialization governance bodies

- Develop Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks

- Represent GRA on the product team

- Develop registration strategies and plans aimed at achieving regulatory approval and product labeling

- Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent

- Lead the planning and implementation of global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)

- Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)

- Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment

- Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) is assessed and incorporated into the global regulatory strategy

- Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood

- Ensure effective regulatory agency communications by leading core re