Sr. Scientist, Regulatory Affairs

Imsapharma Com Ar

Base: $106,200.00 - $167,200.00; bonus/equity: eli...
Hybrid
Labeling strategy development
Core labeling documents
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 (e.g., CCDS, CCPPI, CCIFU), US Labeling, and EU Labeling for marketed products.
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable, and we offer a comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits, retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

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, sick days

Skills & Requirements

Must-have

  • labeling strategy development
  • core labeling documents
  • US labeling requirements
  • EU labeling requirements
  • cross-functional team leadership
  • regulatory submissions support

Nice-to-have

  • active listening skills
  • proactive problem-solving
  • tolerance for ambiguity
  • action-oriented mindset
  • influencing and negotiation skills

Key Requirements

  • Minimum of 3 years of labeling experience
  • Bachelor's degree in scientific or medically related discipline
  • Advanced degree (M.S., Pharm.D, Ph.D.) preferred
  • Experience leading cross-functional labeling teams
  • Ability to assimilate clinical and scientific information
  • Understanding of medical concepts and terminology
  • Project management skills
  • Strong written and oral communication skills
  • Attention to detail and accuracy

Work Rights

Not specified

Tailored Resume

Cover Letter