Início Arábia Saudita Regulatory Affairs and Scientific Office Manager
Início Arábia Saudita Regulatory Affairs and Scientific Office Manager
Regulatory Affairs and Scientific Office Manager
Detalhes do emprego
Job Location RIYADH OLAYA TOWERS OFFICE Job Description Guides and influencestechnicalproject 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.
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Hiring company
Procter & Gamble
-
Health and Safety Certificate Level 2 Alpha AcademyAED 92
AED 1,543Duração: Upto 8 Hours -
Level 3 Diploma in Professional Chef Alpha AcademyAED 92
AED 1,837Duração: Upto 2 Days
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