Regulatory Affairs Director

Company: Amgen Inc.
Location: Thousand Oaks
Posted on: November 22, 2021

Job Description:

Career Category
Regulatory
Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Regulatory Affairs Director

Live

What you will do

Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the General Medicine Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.

In this vital, product-facing role you will lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The purpose of Regulatory Affairs Director is:

• To lead GRTs within Amgen's GRAAS organization
• 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 GRTs
  • Represent Regulatory on the product team and other key commercialization governance bodies
  • Develop Global Regulatory Strategic 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, 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 Regulatory on external partnership teams at the product level
    
    While this position is based in Thousand Oaks, a remote work arrangement will be considered.
    
    Win
    
    What we expect of you
    
    We are all different, yet we all use our unique contributions to serve patients. The regulatory professional we seek is a leader with these qualifications.
    
    Basic Qualifications:
    
    Doctorate degree and 4 years of regulatory experience in biotech or science
    Or
    
    Master's degree and 8 years of regulatory experience in biotech or science
    Or
    
    Bachelor's degree and 10 years of regulatory experience in biotech or science
    
    Preferred Skills:
    
    • 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
      Thrive
      
      Some of the vast rewards of working here
      
      As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
      
      • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
      • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
      • Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
        Apply now
        
        for a career that defies imagination
        
        Objects in your future are closer than they appear. Join us.
        
        careers.amgen.com
        
        .

Keywords: Amgen Inc., Thousand Oaks , Regulatory Affairs Director, Executive , Thousand Oaks, California