Regulatory Affairs and Scientific Office Manager

Job Location

RIYADH OLAYA TOWERS OFFICE

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.

Job Schedule

Full time

Job Number

R000120604

Job Segmentation

Experienced Professionals (Job Segmentation)Starting Pay / Salary Range