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Contract TypeContract TypeFull-time
Workplace typeWorkplace typeOn-site
LocationLocationRiyadh

About the Role

Viatris, a global healthcare company, is seeking a highly experienced Regulatory Affairs Senior Manager to join its team in Riyadh, Saudi Arabia. This role is central to leading and executing regulatory strategies within the Kingdom of Saudi Arabia, ensuring the efficient registration of medicinal products in alignment with commercial objectives. The Senior Manager will provide strategic direction and oversight for Viatris' portfolio and strategic initiatives, addressing diverse healthcare needs.

Key Responsibilities

  • Lead, manage, and provide strategic direction for regulatory affairs activities in the Kingdom of Saudi Arabia (KSA).
  • Oversee the KSA country team, managing the Viatris portfolio and strategic initiatives to develop and execute regulatory strategies, processes, and plans for new registrations and post-approval submissions.
  • Ensure effective communication of regulatory input to regional and local Commercial, Supply Chain, and Quality teams for promoted and development products, and oversee the implementation of special projects.
  • Ensure all regulatory documentation meets relevant regulatory requirements.
  • Apply expert knowledge and interpretation of regulatory requirements in assigned countries to facilitate efficient and effective registration of medicinal products, consistent with supported regions' commercial objectives.
  • Ensure business continuity between vertical regulatory teams, Country Regulatory staff, and distributors supporting regulatory activities for the Viatris portfolio.
  • Provide direct line management of the Viatris RA team, requiring hands-on execution in the market.
  • Apply regulatory expertise for assigned countries to enable the preparation of high-quality documentation and assure compliance with departmental procedures.
  • Ensure the development of the KSA Market Regulatory Team and maintain a comprehensive knowledge base of country requirements and the regulatory environment.
  • Build and foster in-country relationships with stakeholders and partners, ensuring clear communication of regulatory strategy and timelines.
  • Manage the performance of direct reports to achieve agreed objectives and identify and address training and development needs.
  • Provide input to the regulatory strategy for product development in line with business objectives, ensuring strategies are adequately reflected in relevant country plans and alignment is achieved between regulatory activities and country business/commercial plans.
  • Implement team spirit and activities in alignment with Viatris' culture and values.
  • Liaise with Global Regulatory, Vertical Regulatory Teams, Viatris Global Supply, Submissions Management, Market Regulatory Teams, Labeling CoE, Artwork coordinators, Cluster/Market, and other key stakeholders to ensure filing strategies are defined and executed, meeting Health Authority requirements.
  • Ensure appropriate regulatory systems and databases are updated in a timely manner and utilize a submission planning and forecasting tool to update timelines.
  • Facilitate and support all product lifecycle regulatory work, and liaise with Vertical Regulatory Teams, Submissions Management, Cluster/Market, and other key stakeholders.
  • Oversee the preparation of regulatory strategies and plans for assigned countries, including the review of existing regulatory guidelines and relevant literature.
  • Provide input to the local/regional Viatris commercial strategic planning process.
  • Advise on the receipt, distribution, and response to regulatory queries from target countries, consistent with procedures, and liaise with response team members to ensure response targets are met.
  • Develop a detailed understanding of regulatory guidelines and technical requirements, support the maintenance of the regulatory requirements database, and assist Regulatory Policy with assessing the regulatory environment and identifying relevant trends.
  • Follow up with Market Regulatory Teams and distributors on the progress of registration submission and approval activities, and advise line management of progress in regulatory filings.

Qualifications and Requirements

  • Bachelor's degree or equivalent in Chemistry, Pharmacy, or a related life science.
  • A Master's degree (MSc), MBA, or PhD may be an advantage.
  • Must be a Saudi National.
  • Must be licensed by the Saudi Commission for Health Specialties (SCFHS).
  • Minimum of 10 years of experience in regulatory affairs, preferably in human medicines.
  • Demonstrated regulatory experience with a pharmaceutical company, with proven examples of contribution.
  • Proven ability to manage complex regulatory issues and consistently deliver to time, cost, and quality standards.
  • Regional regulatory experience, including knowledge of NDA, sNDA, ANDA, MAA submission processes, and Product Lifecycle Management processes.
  • Demonstrated experience of effective delivery in a complex matrix environment.
  • Knowledge of the Regional and Global Regulatory environment.
  • Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
  • Knowledge of drug development, regulations, and guidelines.
  • Understanding of the pharmaceutical industry, clinical trials, and pharmacovigilance.
  • Knowledge and understanding of quality systems, processes, audit, and inspection.

Required Skills

  • Regulatory Affairs
  • Regulatory Strategy
  • New Registrations
  • Post Approval Submissions
  • Regulatory Documentation
  • Medicinal Product Registration
  • Business Continuity
  • CMC Submissions
  • Product Lifecycle Management
  • Regulatory Guidelines
  • Regulatory Policy
  • Quality Systems
  • Leadership
  • Management
  • Communication
  • Negotiation
  • Interpersonal Skills
  • Analytical Thinking
  • Talent Development
  • Change Agile

Work Environment and Reporting

This is a full-time position based in Riyadh, Saudi Arabia. The Regulatory Affairs Senior Manager reports to the Head of MENA Regulatory Affairs. Direct reports include Country Regulatory Teams. Key stakeholders include Middle East Country and Cluster Commercial Leads, Supply Chain and Quality, and Vertical Regulatory Leads. The role manages approximately 3-5 colleagues, including direct and indirect reports, and individuals with matrix responsibility or contingent workers.

Requirements

  • Requires +10 Years experience

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