Regulatory Affairs Director – Global Regulatory Leader, Rare Disease

Role Overview

• 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
• 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
• Leads GRT to develop and execute team goals
• Provides coaching and mentoring to GRT members
• Integrates regional regulatory representative input into GRT and regulatory plans
• Communicates and ensures alignment of global functional and cross-functional goals and objectives
• Represents Global Regulatory Affairs on key commercialization teams (e.g, PT, EGT, GST)
• Represents Amgen GRA on external partnership teams at the PT level
• Provides education and training on regulatory strategies and compliance issues to other PT functions
• Ensures regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments)
• Advocates for Amgen/GRAAS by building strong relationships with key external stakeholders including senior regulatory agencies, trade associations, and influential professional bodies
• Works externally to influence regulatory legislative environment in line with Amgen policy priorities for the therapeutic area
• Develop regulatory due diligence assessment of licensing/acquisition opportunities as assigned by management.

Requirements

• Doctorate degree and 4 years of directly related experience OR Master’s degree and 8 years of directly related experience OR Bachelor’s degree and 10 years of directly related experience
• At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
• Demonstrated ability to lead teams
• Strong communication skills
• both oral and written
• Ability to understand and communicate scientific/clinical information
• Understanding of regulatory activities and how they affect projects and processes
• Ability to anticipate and mitigate against future strategic issues & uncertainties
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome – influencing and negotiation skills
• Cultural awareness and sensitivity to achieve results across both regional country and International borders.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
• Group medical, dental and vision coverage
• Life and disability insurance
• 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
• Flexible work models where possible.