Senior Manager - Regulatory & Policy Affairs

Role Overview

Senior Manager – Regulatory & Policy Affairs at Procter & Gamble (P&G), located in Riyadh, Saudi Arabia. This role reports to the Director of Research & Development, Regulatory Affairs Middle East & Africa, and is responsible for the Saudi Arabia market within P&G Personal Healthcare.

Company Overview

P&G is a globally recognized company with a portfolio of trusted, quality leadership brands including Always®, Ariel®, Gillette®, Head & Shoulders®, Herbal Essences®, Oral-B®, Pampers®, Pantene®, Tampax® and more. The company operates in approximately 70 countries worldwide and is committed to growing business leaders and fostering diversity and inclusion across its operations.

Role Purpose

This role exists to advance P&G Personal Healthcare's growth in the Kingdom of Saudi Arabia by leading regulatory strategies and policy engagement that enable timely product approvals and sustainable market access. You will develop and execute Regulatory Affairs strategies across the product lifecycle while supporting Policy Affairs efforts to advocate for science-based policies and an enabling regulatory environment for innovation and patient access.

Key Responsibilities

Regulatory Strategy & Lifecycle Management

• Lead and coordinate day-to-day Regulatory Affairs activities for assigned products and initiatives, ensuring alignment with regional and global regulatory strategies.
• Develop and execute Regulatory Affairs strategies across the product lifecycle from regulatory pathway assessment and submissions to approvals and compliance.
• Prepare, compile, and manage regulatory dossiers, including responses to health authority queries and regulatory correspondence in accordance with applicable guidelines and country-specific requirements.
• Achieve product registrations within agreed timelines and maintain dossiers post-registration to ensure compliance with corporate and health authority legal requirements, including submission of variation documents.
• Update and maintain regulatory files and records, including appropriate archiving of all relevant documentation in accordance with applicable internal company standards.
• Define accurate timelines to ensure renewal of product registrations.
• Review and ensure conformity of product artworks, promotional materials and tools with marketing code and legal requirements.

Compliance & Risk Management

• Ensure compliance with global, regional, and local regulatory requirements by implementing and maintaining appropriate processes, policies, standard operating procedures, and working instructions.
• Proactively identify potential regulatory risks and develop strategies to ensure continuous compliance and business continuity.
• Lead, monitor, assess, and communicate risks on key projects, providing regular updates to stakeholders and Senior Management.
• Monitor progress of applications against set timelines, acting where necessary to minimize delays and anticipate difficulties and challenges.

Stakeholder Management & Relationships

• Build and maintain effective relationships with regulatory authorities, health authorities, distributors, and relevant external stakeholders to support transparent communication and facilitate regulatory processes.
• Liaise with regulatory authorities, government bodies, industry associations, and trade associations to achieve and maintain product registrations.
• Develop relationships with regulatory bodies to represent the interests of the organization, gain relevant information, and help shape change.
• 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.
• Establish relationships across departments to handle and deliver departmental results.

Policy & Advocacy

• 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 policy makers; creating political allies; and building coalitions.
• Monitor legislative developments and identify emerging issues to the company; in coordination with management and global government relations and public policy function, develop company positions and priorities on public policy issues that impact P&G's business and position.
• Utilize P&G Government Relations resources, policies, and expertise to achieve the company's political and business objectives.

Team Leadership & Development

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

Strategic Support & Communication

• Provide strategic guidance and support to cross-functional teams, ensuring regulatory considerations are integrated into product development and business processes.
• 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.
• Design or source health economic projects to optimize messaging and favorable perception and adoption of products, technologies, and procedures as required.
• Communicate information and present status updates on product and project activities to key internal and external stakeholders when requested.

Qualifications & Experience

• Saudi Licensed Pharmacist from Saudi Commission for Health Specialities.
• 5 years or more in Pharmaceutical or Personal Healthcare Regulatory Experience.
• Experience from a multi-national or regional company is required.
• Experience in Pharma and Consumer Personal Healthcare products.

Skills & Competencies

• English and Arabic fluency (oral and written).
• Proven ability to effectively negotiate with SFDA on technical and policy matters to drive optimal outcomes.
• Excellent oral and written communication skills, interpersonal skills, and influencing skills.
• Effective communication with different audiences.
• Negotiations, coalition, and effective lobbying skills.
• Team collaboration and ability to establish relationships across departments.

Additional Information

• Full-time position.
• Job Number: R000147983.
• Job Segmentation: Experienced Professionals.
• P&G is an equal opportunity employer and values diversity. The company does not discriminate against individuals on the basis of race, color, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, HIV/AIDS status, or any other legally protected factor.