Senior Manager - Regulatory & Policy Affairs

Overview Of The Job

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.

Core Regulatory & Policy Practices

• 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.

Qualifications & Technical Skills

• Saudi Licensed Pharmacist from Saudi commission for health specialities
• Years of Experience: 5 Years or more 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 from a multi-national or regional company is required.
• Experience in Pharma & Consumer Personal Healthcare products
• Excellent Oral & written communication skills, interpersonal, and influencing skills.
• Effective communications with different audiences.
• Negotiations, Coalition, and effective lobbying skills.
• Team activity, collaborative individual and must have the ability to establish relationships across departments to handle and deliver departmental result

About Us

Job Qualifications

• Saudi Licensed Pharmacist from Saudi commission for health specialities
• Years of Experience: 5 Years or more in Pharmaceutical/ Personal Healthcare Regulatory Experience
• Language: English and Arabic Fluency.

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