Regulatory Affair Director - Global Regulatory Leader (Rare Disease)

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. 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 Affair Director - Global Regulatory Leader (Rare Disease)

What you will do

Let’s do this. Let’s change the world. The Global Regulatory Leader (GRL) is a product facing role that leads the Global Regulatory Team in the Regulatory Affairs organization. In this vital role you will lead one or more Global Regulatory Teams within Amgen’s Global Regulatory Affairs department and 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. Additionally, you will provide regulatory expertise and guidance to product teams (eg, Product Team (PT), Evidence Generation Team (EGT), Global Safety Team (GST))

Key Responsibilities:

STRATEGY AND EXECUTION

• Develops Global Regulatory Strategic Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan
• Represents GRA on PT and EGT to ensure development of product registration strategies and development plans aimed at achieving regulatory approval and product labeling
• Provides 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
• Leads development, review and approval of the target product label (TPL)
• Obtains input from the GRT members (e.g. RRLs, RA CMC, Safety, etc.) to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance
• Leads the planning and implementing global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)
• Ensures consistency of evidence-based global product communication (e.g. regulatory submission documents)
• Conducts contingency regulatory planning/risk assessment for global product development strategies and agency interactions
• Monitors and assess impact of relevant global regulations, guidances, and current regulatory environment
• Ensures guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, Breakthrough Therapy or PRIME designations, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) are assessed and incorporated into the global regulatory strategy
• Consistently communicates well defined, successful regulatory strategies throughout the organization such that expectation is understood
• Produces strategies that provide innovative alternatives which communicate the associated risks
• Communicates Amgen’s position consistently cross-functionally and across all documents
• Develops the ability to articulate and educate the likelihood of regulatory success based on proposed strategies
• Develops ability to accurately predict expectations and outcomes by regulatory agencies

HEALTH AUTHORITY INTERACTIONS

• Directs global regulatory agency interaction strategies, in collaboration with regional colleagues
• Ensures effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)
• Ensures consistent communication of product information to Health Authorities
• Attends key regulatory agency meetings which could impact the global product strategy

COLLABORATION

• Leads GRT to develop and execute team goals
• Provides coaching and mentoring to GRT members
• Integrat