Operations and Process Lead - Regulatory Product Owner

Responsibilities

• Support Regulatory Affairs teams with operational management and the use of regulatory systems.
• Act as a conduit between system end users and Tech colleagues to develop and enhance business solutions.
• Ensure GxP requirements, compliance, and inspection readiness are maintained.
• Manage validation documentation and support audit, assessment, and inspection readiness.
• Collect, maintain, and prioritize user requirements for applicable applications and solutions.
• Manage a team of Support Specialists providing services to business partners.
• Oversee user acceptance testing (UAT), including preparation, execution, and identifying efficiencies.
• Plan, monitor, and manage projects from initiation through completion, including resourcing and reporting.
• Manage System Access Plans and user account oversight activities.
• Provide SME input for the development and maintenance of 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 leading teams and managing people.
• Experience working with validated document management systems.
• Strong understanding of regulatory processes and major agency regulations (FDA, EMA, PMDA, MFDS, NMPA) and ICH GxP.
• Experience with Agile delivery methodology and the system development life cycle.
• Proficiency with JIRA for backlog and requirement management.

Preferred Qualifications

• Technical background with proficiency in regulatory or clinical systems and reporting capabilities.
• Familiarity with MS O365.
• Excellent interpersonal, written, and verbal communication skills.
• Ability to identify opportunities for process and compliance improvements.
• Strong customer service orientation with the ability to communicate with both technical and non-technical audiences.

About the Company

Haleon is a purpose-driven, world-class consumer company putting everyday health in the hands of millions. Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. We are driven by an agile, performance-focused culture and a mission to deliver better everyday health with humanity.