Manager, Regulatory Affairs - Otc

Haleon

Warren, NJ, USA
Base: $122,621 - $168,603; bonus: 12% on-target an...
Hybrid
Bachelor's degree in life sciences
4-7 years regulatory experience
Fda submission support experience
This role is accountable for end-to-end execution of regulatory activities for the diverse US OTC portfolio including monograph, NDA products, and medical devices

Job Summary

  • This role is accountable for end-to-end execution of regulatory activities for the diverse US OTC portfolio including monograph, NDA products, and medical devices.
  • The position requires independently authoring routine regulatory submissions and directly engaging with the FDA to address straightforward matters.
  • Haleon offers a robust Total Reward package including competitive pay, a 12% on-target annual bonus, and comprehensive benefits like healthcare coverage starting day one.

Matching Summary

This role is accountable for end-to-end execution of regulatory activities for the diverse US OTC portfolio including monograph, NDA products, and medical devices.

Salary

Base: $122,621 - $168,603; Bonus: 12% on-target annual bonus; Benefits: Generous 401(k), tuition reimbursement, 6 months paid parental leave

Skills & Requirements

Must-have

  • Bachelor's Degree in Life Sciences
  • 4-7 years regulatory experience
  • FDA submission support experience
  • OTC/NDA/CMC regulatory knowledge
  • Cross-functional project leadership

Nice-to-have

  • Advanced degree or professional certification
  • Experience at global pharmaceutical company
  • Project management experience
  • Growth mindset and love of learning
  • Interest in applying AI tools

Key Requirements

  • Bachelor's Degree in Pharmaceutical or Life Sciences
  • 4-7 years regulatory experience
  • Experience supporting FDA submissions (OTC/NDA/CMC)
  • Demonstrated ability to lead regulatory projects

Work Rights

Not specified

Tailored Resume

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