Principal Consultant, Labeling Strategy

Opusregulatory

Us
On-site
Labeling strategy and operations
End-to-end labeling process
Us, eu, and ich regulatory requirements
Opus Regulatory is seeking a Principal Consultant for Labeling Strategy to oversee regulatory requirements and develop labeling strategies for various projects. The role requires a minimum of four years of experience in pharmaceutical regulatory affairs, particularly in labeling, and offers a comprehensive benefits package

Job Summary

  • Opus Regulatory has provided strategic guidance to industry partners through expert consultants in key practice areas for over 30 years.
  • The Principal Consultant will lead preparation, review, and update content for Target Product Label (TPL), Company Core Data Sheet (CCDS), and local labeling.
  • Opus offers a comprehensive benefits package including medical, dental, vision, 401(k) plan, and paid time off.

Matching Summary

Match Score: 85

Opus Regulatory is seeking a Principal Consultant for Labeling Strategy to oversee regulatory requirements and develop labeling strategies for various projects. The role requires a minimum of four years of experience in pharmaceutical regulatory affairs, particularly in labeling, and offers a comprehensive benefits package.

Skills & Requirements

Must-have

  • labeling strategy and operations
  • end-to-end labeling process
  • US, EU, and ICH regulatory requirements
  • labeling timelines and deliverables

Nice-to-have

  • experience across multiple therapeutic areas
  • client subject matter expert relationships

Key Requirements

  • Minimum 4 years of experience in pharmaceutical regulatory affairs specializing in Labeling Strategy
  • Bachelor’s degree required
  • Demonstrated global and international experience

Work Rights

Not specified

Tailored Resume

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