Sr. Scientist, Regulatory Affairs

microsatsystems.biz

Base: $106,200.00 - $167,200.00; bonus/equity: ann...
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.
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include 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.

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, 401(k), paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • Global Labeling Strategy
  • Core Labeling Documents
  • US Labeling
  • EU Labeling
  • Cross-functional team leadership

Nice-to-have

  • Assimilation of clinical information
  • Proactive problem-solving
  • Tolerance for ambiguity
  • Influence and negotiation skills

Key Requirements

  • Minimum of 3 years labeling experience
  • Bachelor's degree in scientific/medical discipline
  • Advanced degree preferred (M.S., Pharm.D, Ph.D.)
  • Experience leading cross-functional teams

Work Rights

Not specified

Tailored Resume

Cover Letter