Amgen

Global Regulatory Lead – Obesity and Related Conditions

Amgen

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $200,324 - $245,321 per year

Job Level

Senior

About the role

  • Lead one or more Global Regulatory Teams within Amgen’s Global Regulatory Affairs department
  • 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
  • Provide regulatory expertise and guidance to product teams.

Requirements

  • Doctorate degree and 5 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
  • Contemporary obesity experience desired
  • Demonstrated ability to lead regulatory aspects of highly complex programs in late development
  • Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application
  • 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 and 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.
Benefits
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
  • group medical, dental and vision coverage
  • life and disability insurance
  • flexible spending accounts
  • A discretionary annual bonus program
  • stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategyregulatory requirementsregulatory expertiseregulatory submissionsmarketing applicationnew indication supplemental applicationbiotech experiencescientific informationclinical informationcomplex program management
Soft Skills
leadershipcommunication skillsconflict resolutioncultural awarenessplanningorganizingprioritizationdecision makingproblem solvingorganizational savvy
Certifications
Doctorate degreeMaster’s degreeBachelor’s degree