Overview
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.
Job Location
Riyadh
Team and Success
This role reports to the Director of Research & Development, Regulatory Affairs Middle East & Africa and will look after the Saudi Arabia market. Role success includes regulatory compliance, timely market access, and effective cross-functional collaboration.
Responsibilities
- Lead and coordinate day-to-day Regulatory Affairs activities for assigned products and initiatives, aligning 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 per 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.
- Develop relationships with regulatory bodies to represent the interests of the organization and help shape change.
Core Regulatory & Policy Practices
- Prepare and submit registration dossiers to achieve registration for the specified product portfolio within agreed timelines and maintain post-registration updates to ensure ongoing compliance.
- Ensure renewal of registrations by defining accurate timelines and maintaining regulatory files and records in accordance with internal standards.
- Review product artworks and promotional materials for conformity with marketing codes and legal requirements.
- Liaise with health authorities, distributors, regulatory authorities, and trade associations to achieve and maintain registrations.
- Develop relationships with regulatory bodies to represent the organization’s interests and help shape regulatory change.
- Lead, monitor, and communicate risks on key projects with regular updates to stakeholders and senior management.
- Monitor progress of applications against set timelines and take action to minimize delays.
- Communicate status updates on product/project activities to internal and external stakeholders when requested.
- Affect legislative and executive public policy outcomes by educating, persuading, negotiating with policymakers, building coalitions, and utilizing regulatory resources to achieve business objectives.
- Monitor legislative developments and identify emerging issues to develop company positions and priorities on public policy issues impacting the business.
Role Requirements
- Saudi Licensed Pharmacist from Saudi Commission for Health Specialties
- 5+ years of experience in Pharmaceutical/Personal Healthcare Regulatory Experience
- Language: English and Arabic fluency
- Location: Riyadh, KSA
Soft Skills
- Proven ability to effectively negotiate with SFDA on technical and policy matters to drive optimal outcomes.
- Experience in a multinational or regional company is required.
- Experience in Pharma & Personal Healthcare products.
- Excellent oral and written communication, interpersonal, and influencing skills.
- Effective communication with different audiences; negotiations, coalition-building, and lobbying skills.
- Team-oriented, collaborative, and able to establish cross-department relationships to achieve results.
About Us
We produce globally recognized brands and grow the best business leaders in the industry. Our brands include Always®, Ariel®, Gillette®, Head & Shoulders®, Herbal Essences®, Oral-B®, Pampers®, Pantene®, Tampax®, and more. Our community operates in approximately 70 countries worldwide. Visit http://www.pg.com to know more. We are an equal opportunity employer and value diversity. We do not discriminate 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.