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Job Description
The jobs in this level are responsible for supervising/training a number of subordinates at lower levels. Job holders are also responsible for reviewing, analyzing and approving reports and registration files. Jobs in this level are involved with the development of procedures and contribution to policies and negotiating. they follow-up with regulatory heath authorities to ensure meeting the submission (approval deadlines) and are responsible for enhancing Hikma planned submission strategies execution.
- Implements approved departmental policies and procedures and ensures adherence with the processes implemented. so that work is carried out in a controlled manner.
- Implements the day-to-day operations assigned for the function to ensure compliance with the established standards and procedures.
- Supervises the activities and work of subordinates to ensure that all work within a specific area is carried out in an efficient manner and in compliance with the set policies, processes and procedures.
- Participates in the development of R&D department policies, and procedures and ensures implementation of all relevant procedural/legislative requirements.
- Follows up regularly with authorities, internal departments and agents on related submissions and files to ensure meeting deadlines and negotiates with health authorities regarding the registration requirements to enhance execution of Hikma planned submission strategies.
- Reviews, analyzes and approves reports prepared by lower level positions to ensure that reports meet the requirements.
- Provides feedback in the 5-YBP on registration pathways, timelines and risks in relevant supervised territory.
- Generates annual registration plans and monthly plan executions covering new product registration and all maintenance of registrations required per territory.
- Updates and trains concerned departments on new regulations regarding drug authorization to spread awareness and understanding.
- Complies with all relevant safety, quality, health and environmental procedures to ensure a healthy and safe work environment.
Job Requirements
- BSc. of Pharmacy.
