Senior Manager Regulatory & Policy Affairs📣 إعلان

Role Summary

Procter & Gamble Saudi Arabia is seeking a Senior Manager - Regulatory & Policy Affairs to join its team in Riyadh. This full-time role is central to advancing P&G Personal Healthcare’s growth within the Kingdom of Saudi Arabia by leading regulatory strategies and supporting policy engagement. The position aims to enable timely product approvals and ensure sustainable market access. This role reports to the Director of Research & Development, Regulatory Affairs Middle East & Africa, with a primary focus on the Saudi Arabia market.

Strategic Regulatory Leadership

The Senior Manager will develop and execute comprehensive Regulatory Affairs strategies across the entire product lifecycle, from initial pathway assessment and submissions to approvals and ongoing compliance. This involves ensuring strict alignment with local regulatory requirements and contributing to an enabling regulatory environment for innovation and patient access.

• 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.
• 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.
• Lead, monitor, assess, and communicate risks on key projects, providing regular updates to stakeholders and senior management.

Policy Affairs and Stakeholder Engagement

This role supports Policy Affairs efforts through engagement with regulatory authorities, government bodies, and industry associations. The objective is to advocate for science-based policies and contribute to a favorable regulatory environment for innovation and patient access.

• 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.
• Affect legislative and executive public policy outcomes by educating, persuading, and negotiating with policymakers; creating political allies; building coalitions; and utilizing 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.

Core Regulatory Operations

The role involves managing the preparation, compilation, and submission of regulatory dossiers, alongside maintaining compliance post-registration and ensuring all documentation meets corporate and health authority requirements.

• 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.
• Prepare and submit registration dossiers to achieve product registration within agreed timelines.
• Update and maintain dossiers post-registration to ensure compliance with corporate and health authority legal requirements, including the submission of variation documents.
• Ensure the renewal of product registrations by defining accurate timelines.
• Maintain and update regulatory files and records, including appropriate archiving of all relevant documentation in line with applicable internal company standards.
• Review and ensure the conformity of product artworks, promotional material, and tools with marketing codes and legal requirements.
• Liaise with health authorities, distributors, regulatory authorities, and trade associations to achieve and maintain registrations.
• Monitor the progress of applications against set timelines, acting where necessary to minimize delays and anticipate difficulties/challenges.
• Communicate information and present status updates on product/project activities to key internal/external stakeholders.

Qualifications and Requirements

Candidates must meet the following essential qualifications and possess the specified experience:

• Saudi Licensed Pharmacist from the Saudi Commission for Health Specialties.
• 5+ years of experience in Pharmaceutical/Personal Healthcare Regulatory Affairs.
• Fluency in English and Arabic is required for effective communication.

Work Environment

This is a full-time position based in Riyadh, Saudi Arabia. The role requires strong regulatory expertise, strategic thinking, and effective stakeholder management to navigate complex regulatory landscapes and ensure compliance.