Operations and Process Lead - Regulatory Product Owner

Responsibilities

• Act as a conduit between regulatory end users and technical teams to enable the development and enhancement of system solutions.
• Manage operational processes, regulatory systems, and ensure GxP requirements and inspection readiness are maintained.
• Lead and manage a team of Support Specialists providing services to business partners.
• Collect, prioritize, and manage user requirements, JIRA backlogs, and system access plans.
• Oversee user acceptance testing (UAT), including preparation, execution, and confirmation of acceptance criteria.
• Plan, monitor, and manage projects from initiation to completion, ensuring deliverables meet timelines and requirements.
• Support audit, assessment, and inspection readiness by maintaining compliance and validation documentation.
• Drive continuous improvement by optimizing processes and providing input for written standards and training content.

Requirements

• Bachelor's degree in life sciences, information technology, or a related field.
• 7 years of experience in the pharmaceutical or consumer goods industry.
• Minimum of 5 years of experience specifically within Regulatory Affairs.
• Proven experience in team leadership and people management.
• Experience working with validated document management systems.
• Strong understanding of regulatory processes and major agency regulations (FDA, EMA, PMDA, MFDS, NMPA, and ICH GxP).
• Knowledge of Agile delivery methodology and JIRA backlog management.

Preferred Qualifications

• Technical background with proficiency in regulatory or clinical systems and MS O365.
• Excellent interpersonal, written, and verbal communication skills.
• Ability to communicate effectively with both technical and non-technical audiences.
• Strong attention to detail and a self-motivated approach to problem-solving.

About the Company

Haleon is a purpose-driven, world-class consumer company dedicated to putting everyday health in the hands of millions. With a trusted portfolio of brands including Sensodyne, Panadol, Advil, and Centrum, we combine deep human understanding with trusted science to deliver better everyday health with humanity.