Regulatory Affairs Director - Global Regulatory Leader (General Medicine/Metabolic)

• 5000 - 6000 USD per Month
• Full Time
• Posted : 3 months ago

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.

Regulatory Affairs Director - Global Regulatory Leader (General Medicine/Metabolic)

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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 – Metabolic 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 role of the Regulatory Affairs Director is to:

• Lead GRTs within Amgen’s GRAAS organization,
• 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, and
• Provide regulatory expertise and guidance to product teams.
  
  

• 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
  
  

• 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
• Negotiation skills
  
  

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible
  
  

Skills

• Biotechnology
• Commercialization
• Communication
• Cultural Awareness
• Environmental Impact Assessment (EIA)
• Organization skills
• Product Strategy