Job Purpose:

The Regulatory Affairs Specialist acts as a link between the company and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation and versus plan timelines

We Are Hiring Senior Regulatory Affairs Specialist

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 of company’s values, code of ethics and social charter.
• Respect of personal data protection charter