Job Description

Guides and influences technical project direction and solves significant technical problems by leveraging scientific/engineering skills and strong foundational GPS understanding developed through hands-on experimentation/application. Performs Application work and demonstrates implementation skills leveraging knowledge that moves projects forward and also begins to gain exposure to and demonstrate initial proficiency in performing integration work.​ Acts as point of accountability within the Global Safety Surveillance & Analysis function for post-marketing adverse event data assessment and interpretation. Demonstrates expertise (understanding of technical fundamentals/practical application) in regulatory with expertise in supporting one or more categories within a BU. Critically evaluates regulatory laws, develops regulatory strategies, identifies/measures key issues/risks and develops strategic plans to address these issues. Reapplies proven regulatory strategies; previous successful approaches.

Core Regulatory 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.

Job Qualifications

A Saudi Pharmacist with a license from the Saudi Commission for Health Specialties.

Good knowledge and experience of the regulatory environment and regulation of drugs, food supplements, medical devices, and cosmetics in Saudi Arabia.

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