Sr Manager, US Regulatory Operations & Compliance

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Advil, Voltaren, Theraflu, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.

The Sr Manager, US Regulatory Operations & Compliance, is responsible for regulatory operational and compliance activities for the US, including Puerto Rico. The position is accountable for maintaining knowledge of evolving regulatory information systems and makes recommendations regarding potential application within the organization. Specifically, the position is accountable for compliance with evolving regulatory frameworks and relationships with the FDA related to reporting, establishment registration, drug listing, and document management.

In addition, this position is also responsible for identifying and supporting process improvements and data management according to company requirements. This includes serving as a primary contact for key cross-functional teams.

Role Responsibilities

• Process Expertise: Responsible for developing, implementing and monitoring simple, compliant, fit for purpose processes. Includes responsibility for maintaining process documents in a controlled manner through available technology (eDMS).

• System Administration: Create and Maintain repositories of current US regulatory documents in a controlled environment (i.e., eDMS, onsite and offsite storage); serve as official point of contact as US Regulatory Affairs (USRA) Administrator for Veeva Vault and any other systems needed; collaborate with USRA and cross functional team on technology solutions and serve as process expert on implementation

• FDA Reporting Lead: Work with and help guide the team that compiles inputs for registration and reporting activities for FDA (i.e, Annual Reports, CARES reporting, etc); oversee process for all cross functional inputs, timelines for assigned reports, and any associated systems

• Inspection Lead: Lead inspection-related activities including preparing for and leading regulatory inspections (e.g., able to directly lead internal and external inspectional activities).

• Structured Product Labeling (SPL) and Registration Lead: SPL generation and review, as needed; oversee process, timelines, and any associated systems; oversee US establishment registrations to ensure current compliance

• Training Coordination: Responsible for liaising with cross-functional teams to maintain USRA role-specific curricula; evaluate changes as needed; and support compliance

• Lead Special Projects: Serve as Key Point of Contact/Lead as business needs arise (e.g., legal entity changes, business partnerships)

• Ex-US Support: Support Certificate of Pharmaceutical Product (CPP) signatory needs on site as necessary

• Performs related duties as assigned (remote or onsite as needed)

Why you?

Basic Qualifications:

• Minimum 8 years of experience in Regulatory Affairs, Medical Affairs, Consumer Safety or related role with knowledge of pharma or OTC drug regulations.

• Bachelor’s degree

• Experience with compliance within US regulatory environment

• Knowledge of medical or pharmaceutical terms

• Demonstrated ability to lead projects or cross-functional teams

• Strong organizational skills with out-of-the-box thinking.

• Excellent oral and written communications skills, stakeholder management and enjoys working in multidisciplinary teams

Preferred Qualifications:

• Advanced degree in business, quality or scientific disciplines

• Experience at a large global pharmaceutical or OTC CPG company

• Experience working on global teams

• Project management experience

• History of communication with FDA (including drug listing and establishment registrations, annual reports, inspections and audits)

• Experience in document management, including Veeva

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigor and risk

• Leading individual and team performance

• Commitment to delivering high quality results, overcoming challenges, focusing on what matters, executi