Regulatory Affairs Senior Manager

Responsibilities

• Provide regulatory management, governance, and expertise to ensure products are successfully introduced or maintained globally within the Oral Health category
• Act as a Business Partner by providing regulatory advice on drug, cosmetic, device, food, and supplement development
• Develop novel regulatory strategies to secure competitive approvals and accelerate speed to market
• Prepare CMC sections for medicinal registration files, PIFs, MDTFs, and clinical trial applications
• Perform CMC evaluations for potential changes and ensure regulatory compliance through appropriate internal change controls
• Communicate technical regulatory requirements and guidelines to cross-functional project teams
• Support the development of strong product claims aligned with consumer insights and regulatory requirements
• Supervise or mentor team members and lead non-product related functional activities to improve company processes

Requirements

• 10+ years of professional experience in a regulatory capacity
• Bachelor’s degree in science (Life Science, Consumer Healthcare, Pharmaceutical Science, R&D, or Regulatory Affairs)
• Proven expertise in scientific interpretation, evaluation, and communication of technical information
• Demonstrated ability to manage multiple complex projects or tasks simultaneously
• Strong strategic regulatory thinking with the ability to plan and organize regulatory pathways
• Ability to interface effectively with R&D, supply chain, and commercial counterparts

About the Company

Haleon is a purpose-driven, world-class consumer company dedicated to putting everyday health in the hands of millions. Our trusted portfolio includes leading brands such as Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum®. We combine deep human understanding with trusted science to deliver better everyday health with humanity.