Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Regulatory Affairs Senior Director - Global Regulatory Leader – Obesity

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will support products in the Obesity 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.

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

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 5 years of regulatory experience in biotech or science

OR

Master’s degree and 8 years of regulatory experience in biotech or science

OR

Bachelor’s degree and 10 years of regulatory experience in biotech or science

Preferred Qualifications:

• Contemporary obesity 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 communic