GRL - Regulatory Affairs Director

Thousand Oaks, CA, US
Jun 14, 2019
Required Education
Position Type
Full time
Amgen is seeking a Regulatory Affairs Director to work out of our Thousand Oaks, CA location supporting products in the Inflammation, Metabolic, and Endocrine therapeutic areas.

Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle 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 the Regulatory Affairs Director is:
  • To lead GRTs 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.

The responsibilities of the Regulatory Affairs Director position are:
  • Develop and execute the global regulatory product strategy
  • Lead global regulatory team(s)
  • Represent GRA on the product team and other key commercialization governance bodies.
  • Develop Global Regulatory 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
  • Represent GRA on the product team
  • Develop registration strategies and 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
  • Lead the planning and implementation of 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) is assessed and incorporated into the global regulatory strategy
  • Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood.
  • 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
  • Represent Amgen GRA on external partnership teams at the product level

Basic Qualifications
Doctorate degree and 4 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

Preferred Qualifications
  • 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 & 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

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.