Sr. Scientist, Regulatory Affairs

medhunter.de

Base: $106,200.00 - $167,200.00; bonus/equity: eli...
Hybrid
Global labeling strategy
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; and supporting country Regulatory Affairs in the development and maintenance of other country’s Local Labeling.
  • The salary range for this role is $106,200.00 - $167,200.00. 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: Medical, dental, vision healthcare and other insurance benefits, retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

Skills & Requirements

Must-have

  • Global Labeling strategy
  • Core Labeling documents
  • US Labeling
  • EU Labeling
  • cross-functional teams
  • labeling expertise and guidance

Nice-to-have

  • respectfully challenge one another’s thinking
  • action-oriented
  • tolerance for ambiguity
  • proactive problem-solving ability

Key Requirements

  • Minimum of 3 years of labeling experience
  • Bachelor’s degree in a scientific or medically related discipline
  • Advanced degree (M.S., Pharm.D, Ph.D.) preferred

Work Rights

Not specified

Tailored Resume

Cover Letter