Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology

About this role

Career Category
RegulatoryJob 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.

Senior Director, Regulatory Affairs - Global Regulatory Leader – Oncology

What you will do

Let’s do this. Let’s change the world. Amgen is seeking a Senior Director, Regulatory Affairs supporting products in the Oncology 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 one or more the Global Regulatory Teams (GRT) in the Regulatory Affairs organization. The purpose of the Global Regulatory Affairs Senior Director is:

• To lead GRTs within Amgen’s GRAAS organization

• To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, 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

• To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications

Key Responsibilities include:

• Develop and execute global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs

• Lead GRTs

• Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives

• Independently develop the 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

• 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

• Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)

• Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)

• Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment; advise product teams and GRT on implications of pertinent changes

• Assess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast Track Designation, conditional /accelerated approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory strategy

• Clearly and succinctly communicate regulatory strategies, associated risks, mitigations, and contingencies to the organization such that the probability of regulatory success and potential outcomes are well understood

• Lead GRTs and product teams in formal and informal communications with regulatory agencies

• Lead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategy

• Represent Amgen Regulatory on external partnership teams at the product level

• Lead regulatory process improvements and initiatives

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 5 years of regulatory experience in biotech or science

OR

Master’s degree and 9 years of regulatory experience in biotech or science

OR

Bachelor’s degree and 11 years regulatory experience in biotech or science

In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Contemporary oncology experience desired

• Demonstrated ability to lead regulatory aspects of highly complex programs in late development

• Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application

• Ability to lead and build effective teams

• Strong communication skills - both oral and written

• Ability to understand and communicate scientific/clinical information

• Ability to anticipate and mitigate against future strategic…