Senior Manager - Regulatory & Policy Affairs Procter & Gamble

Overview of the job

In this role, you will contribute to advancing P&G Personal Healthcare s growth in the Kingdom of Saudi Arabia by leading regulatory strategies and supporting policy engagement to enable timely product approvals and sustainable market access. You will develop and execute Regulatory Affairs strategies across the product lifecycle from regulatory pathway assessment and submissions to approvals and compliance ensuring alignment with local regulatory requirements.

In parallel, you will support Policy Affairs efforts through engagement with regulatory authorities, government bodies, and industry associations to advocate for science-based policies and contribute to an enabling regulatory environment for innovation and patient access.

The role requires strong regulatory expertise, strategic thinking, and effective stakeholder management to navigate complex regulatory landscapes, ensure compliance, and support improved access for current and future P&G PHC products in the Saudi market.

How Success Looks Like

• You understand regulatory requirements deeply and apply them effectively to ensure compliance for Saudi Arabia market.

• You develop and implement regulatory strategies that streamline product submissions and registrations, resulting in timely market access.

• You build and maintain strong relationships with regulatory authorities, leveraging these connections to partnership for faster route to market.

• You lead and execute training programs for the regulatory team and other departments, ensuring they are informed and up to date on regulatory requirements and best practices.

• You provide strategic guidance and support to cross-functional teams, ensuring regulatory considerations are integrated into product development and business processes.

• Designs or sources health economic projects to optimize messaging and favourable perception/adoption of products/technologies/procedures as required.

• You proactively identify potential regulatory risks and develop strategies to ensure continuous compliance and business continuity.

• You effectively manage and mentor teams, fostering a culture of excellence, collaboration, and professional growth within the regulatory affairs function.

Responsibilities of the role

• Lead and coordinate day-to-day Regulatory Affairs activities for assigned products and initiatives, ensuring alignment with regional and global regulatory strategies.

• Monitor and assess the evolving regulatory landscape across Saudi Arabia, providing strategic insights on regulatory changes and their impact on business operations and product registrations.

• Ensure compliance with global, regional, and local regulatory requirements by implementing and maintaining appropriate processes, policies, SOPs, and working instructions.

• Manage the preparation, compilation, and submission of regulatory dossiers, including responses to health authority queries and regulatory correspondence in accordance with applicable guidelines and country-specific requirements.

• Collaborate cross-functionally with R&D, Commercial, Quality, Supply Chain, and Legal teams to support regulatory strategies that enable efficient product approvals and lifecycle management.

• Build and maintain effective relationships with regulatory authorities and relevant external stakeholders to support transparent communication and facilitate regulatory processes.

• Support the development and execution of Public Policy and advocacy initiatives by engaging with industry associations, government entities, and regulatory bodies to promote science-based, predictable, and innovation-friendly regulatory frameworks.

• Contribute to shaping policy positions and industry proposals that support improved regulatory pathways, market access, and patient access to healthcare products.

u>Core Regulatory & Policy Practices:/u>

• To prepare & submit registration dossiers and to achieve registration for the specific product portfolio, within agreed timelines.

• To update and maintain dossiers post registration, to ensure compliance with corporate and health authority legal requirements. This will include the submission of variation documents.

• To ensure the renewal of registration of products by defining the accurate timelines.

• To ensure maintenance and update of regulatory files and records including appropriate archiving of all relevant documentation in appropriate system in line with applicable internal company standards

• To review and ensure the conformity of the product artworks, promotional material and tools with the marketing code and legal requirements.

• To Liaise with health authorities, distributors, regulatory authorities, and trade associations to achieve and maintain registrations.

• To develop relationships with regulatory bodies to represent the interests of the organization, gain relevant information and help shape change.

• Leads, monitors, assesses, and communicates risks on key projects, providing regular updates to Stakeholders and Senior Management

• Monitors and progress of applications against set timelines, acting where necessary, to minimize delays and anticipate difficulties/challenges.

• Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.

• Affect legislative and executive public policy outcomes by educating, persuading, and negotiating with policy makers; creating political allies; building coalitions; and utilizing the P&G Government Relations resources, policies, and expertise to achieve the company s political and business objectives.

• Monitor legislative developments and identify emerging issues to the company, and in coordination with management and global government relations and public policy function; develop company positions and priorities on public policy issues which impact P&G s business and position.