Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

Amgen • Thousand Oaks, CA

28d

About The Position

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.

Requirements

• Doctorate degree and 5 years of regulatory experience in biotech or science
• Master’s degree and 8 years of regulatory experience in biotech or science
• Bachelor’s degree and 10 years of regulatory experience in biotech or science
• 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 issues and uncertainties
• Ability to resolve conflicts and develop a course of action
• Cultural awareness and sensitivity to achieve global results
• Planning and organizing abilities
• Able to prioritize and manage multiple activities
• Ability to make complex decisions and solve problems
• Ability to deal with ambiguity
• Organizational savvy
• Negotiation skills

Nice To Haves

• 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

Responsibilities

• Lead GRTs within Amgen’s GRAAS organization
• 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
• 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

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees