Sr. Scientist, Regulatory Affairs

Drugdiscovery

Base: $106,200.00 - $167,200.00; bonus/equity: ann...
Hybrid
Labeling content development
Core labeling documents
Us labeling
The purpose of Global Labeling is to drive labeling strategy and ensure high-quality and compliant labeling documents which, provide the safe and effective use of products for patients and healthcare providers globally

Job Summary

  • The purpose of Global Labeling is to drive labeling strategy and ensure high-quality and compliant labeling documents which, provide the safe and effective use of products for patients and healthcare providers globally.
  • As part of Labeling Strategy function in Global Labeling, you will be accountable for developing labeling content and maintaining the target product labeling for developmental products, Core Labeling documents (e.g., CCDS, CCPPI, CCIFU), US Labeling, and EU Labeling for marketed products.
  • We offer a comprehensive package of benefits.

Matching Summary

The purpose of Global Labeling is to drive labeling strategy and ensure high-quality and compliant labeling documents which, provide the safe and effective use of products for patients and healthcare providers globally.

Salary

Base: $106,200.00 - $167,200.00; Bonus/Equity: annual bonus and long-term incentive, if applicable; Benefits: medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

Skills & Requirements

Must-have

  • labeling content development
  • Core Labeling documents
  • US Labeling
  • EU Labeling
  • cross-functional teams
  • regulatory requirements

Nice-to-have

  • active listening skills
  • proactive problem-solving ability
  • tolerance for ambiguity
  • action-oriented
  • influence and negotiate

Key Requirements

  • Bachelor's degree in scientific or medically related discipline
  • Minimum of 3 years of labeling experience
  • Experience in leading cross-functional labeling team
  • Ability to assimilate clinical and scientific information
  • Understanding of medical concepts and terminology
  • Project management skills

Work Rights

Not specified

Tailored Resume

Cover Letter