Director Regulatory Affairs – Global Regulatory Leader

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-28866
The Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. This role is a product facing role that leads the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
The purpose of this role is:
To lead several GRTs and other regulatory staff within Amgen's GRA department
To develop a comprehensive regulatory strategy 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 expertise and guidance to product teams (eg, PST)
Develop and execute the global regulatory product strategy
Lead global regulatory team(s)
Represent GRA on the PST and other key commercialization governance bodies
Develop Global Regulatory Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan. Represent GRA on PST to ensure development of product registration strategies and development plans aimed at achieving regulatory approval and product labeling
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
Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Lead the planning and implementing global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)
Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance's, and current regulatory environment
Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) are assessed and incorporated into the global regulatory strategy
Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood
Produce strategies that provide innovative alternatives which communicate the associated risks
Communicate Amgen's position consistently cross-functionally and across all documents
Interact with Global regulatory agency strategies, in collaboration with regional colleagues
Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)
Attend key regulatory agency meetings which could impact the global product strategy
Lead GRT to develop and execute team goals
Integrate regional regulatory representative input into GRT and regulatory plans
Represent GRA on key commercialization teams (e.g, PST, GDT, GST)
Represent Amgen GRA on external partnership teams at the PST level
Provide education and training on regulatory strategies and compliance issues to other functions
Ensure regulatory compliance for product
Basic Qualifications
Doctorate degree and 4 years of Regulatory experience
Master's degree and 8 years of Regulatory experience
Bachelor's degree and 10 years of Regulatory experience
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications
Demonstrated ability to lead team
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and mitigate against future strategic issues & uncertainties
Ability to resolve conflicts and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities
Managing multiple activities
Making complex decisions
Problem solving abilities
Setting priorities
Dealing with ambiguity
Organizational savvy
Action orientated
Conflict management
Building effective teams
Negotiation skills
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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