Overview

  • Amgen is seeking a Director Regulatory Affairs to work out of our Thousand Oaks, CA location. This position reports to the Executive Director of Regulatory Affairs.
  • 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, Product Strategy Team PST)

The Responsibilities of the Director Global Regulatory Affairs position are:

  • 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.

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

Preferred Qualifications:

  • 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
  • Masters degree
  • 3-5 years of recent Oncology experience
  • Ability to lead and build affective 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 & 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
  • Multi-disciplinary
  • Dealing with ambiguity
  • Organizational savvy
  • Action orientated
  • Conflict management skills
  • Negotiation skills

To apply for this job please visit careers.amgen.com.


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