Senior Regulatory Affairs Specialist - Pharmaceutical

Job Description :

• Plan the review of a new application submission corresponding to company plan as well as 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 on VISTA
• Preparation, submission and follow up of pricing files internally and externally
• Following and complying with all the defined internal policies and procedures of working
• Following and complying strictly with Toll
• companies with all assigned pharmaceutical Products.
• Following up strictly shipment & all logistics of assigned products with our agent
• Following strictly all the Authority Regulations, decisions & degrees
• Carry out all the required communication and follow up required with local affiliate, region & corporate as appropriate.
• Carrying the planned Activities and reflecting the approvals on the internal system
• Revision and approval of Promotional Materials & any updated packaging material
• Perform other duties as assigned.
• Respect for the company’s values, code of ethics and social charter.
• Respect of personal data protection charter

Job Requirements

Job Requirement :

• Bachelor Degree in Pharmaceutical Sciences/ Vet./ Science.
• Females Only
• Experience in Medical Devices is a must
• 2-5 years of experience in a similar position
• V. Good command of English language written & spoken
• Proficiency in MS Office: Word, Excel, PowerPoint