Ad, Regulatory Affairs Cmc

Kenvue

Summit, New Jersey, United States
Base: $166,600.00 - $235,200.00; bonus/equity: not...
Hybrid
Develop regulatory strategies
Manage regulatory submissions
Respond to regulatory information
The Associate Director, Regulatory Affairs CMC, is responsible for developing regulatory strategies and providing guidance to product development and commercial teams

Job Summary

  • The Associate Director, Regulatory Affairs CMC, is responsible for developing regulatory strategies and providing guidance to product development and commercial teams.
  • Key responsibilities include preparing and managing regulatory submissions, analyzing information impacting regulatory decisions, and developing strategies for CMC agency meetings.
  • Kenvue offers a competitive benefit package including paid holidays, vacation, volunteer time, and learning & development opportunities.

Matching Summary

The Associate Director, Regulatory Affairs CMC, is responsible for developing regulatory strategies and providing guidance to product development and commercial teams.

Salary

Base: $166,600.00 - $235,200.00; Bonus/Equity: Not specified; Benefits: Competitive Benefit Package*

Skills & Requirements

Must-have

  • Develop regulatory strategies
  • Manage regulatory submissions
  • Respond to regulatory information
  • Analyze regulatory impact
  • Lead agency meetings
  • Manage change control
  • Analyze legislation and regulation

Nice-to-have

  • Work with industry counterparts
  • Experience in matrix environment
  • Motivate and influence others
  • Passionate about insights and innovation

Key Requirements

  • Minimum of 5 years of experience in Regulatory Affairs
  • Bachelor’s degree in pharmacy, Chemistry, Biology or Pharmacology
  • Experience with INDs, NDAs, ANDA
  • Leading health authority meetings experience
  • OTC industry experience preferred

Work Rights

Not specified

Tailored Resume

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