Regulatory Affair Director - Global Regulatory Leader (Rare Disease) Job at Amgen

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.

Job Responsibility

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
May participate in external review process for commenting based on expertise
May participate in external policy activities as indicated by expertise
As assigned by management, develop regulatory due diligence assessment of licensing/acquisition opportunities

Requirements

Doctorate degree and 4 years of directly related experience
Master's degree and 8 years of directly related experience
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 or resources

Nice to have

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

What we offer

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, 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
Flexible work models where possible

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Regulatory Affair Director - Global Regulatory Leader (Rare Disease)

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