Sr. Scientist, Regulatory Affairs

Newyorkbioconnect

Base: $106,200.00 - $167,200.00; bonus/equity: eli...
Hybrid
Global labeling strategy
Core labeling development
Us labeling requirements
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, US Labeling, and EU Labeling for marketed products.
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. 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: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, 401(k), paid holidays, vacation, and sick days

Skills & Requirements

Must-have

  • Global Labeling Strategy
  • Core Labeling Development
  • US Labeling Requirements
  • Regulatory Submissions Support
  • Cross-functional Team Leadership

Nice-to-have

  • Assimilation of clinical and scientific information
  • Proactive problem-solving ability
  • Tolerance for ambiguity
  • Action-oriented approach

Key Requirements

  • Minimum of 3 years of labeling experience
  • Bachelor’s degree in a scientific or medically related discipline
  • Experience leading cross-functional labeling teams
  • Understanding of medical concepts and terminology
  • Project management skills

Work Rights

Not specified

Tailored Resume

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