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Principal Regulatory Affairs Specialist

1 month ago

New York, United States ACE Partners Full time

Job Description: Principal Regulatory Affairs Specialist


Position Objectives: Lead product strategy, regulatory compliance, market expansion, and change management for consumer products (Rx/OTC, Nutritional, Cosmetics).


Responsibilities:

  • Interpret and apply regulatory policies and guidelines.
  • Innovate and promote successful regulatory submissions.
  • Review scientific information and ensure data supports conclusions.
  • React to regulatory changes and recommend strategies to minimise risk.
  • Influence regulatory stakeholders and shape the regulatory environment.
  • Lead projects and influence cross-functional team members.
  • Work with national opinion leaders and advisory boards.
  • Provide regulatory guidance to project teams.
  • Act as the primary contact with Health Authorities.
  • Review materials and advise on regulatory compliance.
  • Maintain regulatory databases for product accuracy.
  • Mentor and coach team members.
  • Provide technical expertise and participate in industry forums.


Qualifications:

  • Bachelor’s degree preferred.
  • 8+ years in Regulatory Affairs within the consumer product sector.
  • Strong understanding of regulatory processes and systems.
  • Excellent analytical, organizational, and communication skills.
  • Ability to influence stakeholders and handle multiple tasks.
  • Detail-oriented with experience in FDA regulations and CFR.
  • Ability to independently conduct activities and react decisively in unexpected situations.


Join us to drive regulatory excellence and ensure compliance for innovative consumer products Apply now