- Plan the review of a new application submission corresponding to the company plan and the agency guidelines for submission.
- Plan for the review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines
- Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.
- Maintain the products' labelling up to date, implementing global and local labelling decisions, through labelling, review and approval
- Updating the internal DKT DMFs regularly
- Revision and approval of promotional Materials, any updated packaging material
- Preparation, submission and follow up of Medical devices Registration & Required Variations.
- Preparation, submission and follow up of Medical devices importation & release Approvals
- Following and complying with all the defined internal policies and procedures of working
- Following and complying strictly with the Toll companies with all assigned pharmaceutical Products.
- Following up strictly on the shipment & all logistics of the assigned products with our agent
- Following strictly all the Authority Regulations, decisions & decrees
- Carry out all the required communication and follow up needed with local affiliate, region & corporate as appropriate.
- Carrying out the planned Activities and reflecting the approvals on the internal system
- Up to date with all changes in Regulations, Guidelines, EDA electronic Platform.
Bachelor's Degree in Pharmaceutical Sciences/Veterinary./ Science.Commitment, Time Management, dedicatedEager to learn5-8 years of relevant experience