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Associate Director
Global Regulatory CMC Biologics
Posted on 7/22/2022
INACTIVE
Locations
Summit, NJ, USA • Princeton, NJ, USA • Edison, NJ, USA • Lawrence Township...
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Marketing
Research
Requirements
  • 7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy
  • Knowledge of CMC regulatory requirements during development and post-approval and experience with global CMC regulations for small molecule products
  • Knowledge of pharmaceutical development, including drug substance, drug product and analytical methods
  • Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently
  • Ability to identify, communicate and resolve complex issues
  • Prepare and manage filings and ensure thoroughness, accuracy and timeliness
  • Ability to interpret global regulations and guidance
  • Strong oral and written skills
  • Proficient with electronic systems
Responsibilities
  • Represent regulatory CMC on and/or lead matrix teams for small molecule pipeline products and/or commercial products through completion of post-marketing commitments and relevant lifecycle management projects driven by research
  • Independently provide strategic guidance/input related to current regulatory requirements and expectation for small molecule marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products
  • Independently manage and prioritize multiple complex projects
  • Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics
  • Identify, communicate and propose resolutions to routine/complex issues
  • Interpret global regulations and guidance. Identify regulatory opportunity and risks
  • Anticipate and communicate possible regulatory paradigm shifts
  • Participate in product fact finding meetings
  • Review and provide regulatory assessments on change controls
  • Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents
  • Mange relationships with diverse teams
  • Utilize electronic systems for dossier creation and tracking
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company Overview
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.