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Job Description
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
A. Essential Duties and Responsibilities:
- 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
Job Requirements
B. Qualification/Knowledge/Experience:
- Level of education: Bachelor of Pharmacy/Vet./Science
- Experience :
- Previous experience of dealing with regulatory authorities for at least two years is mandated (2 years of experience in similar position in different types of registrations, preferably in multinational organization)
- Experience in working with toll manufacturing companies.
- Experience of registration of Medical Products is essential
- Knowledge of Pharmacovigilance and CTD is desired
- Language :Fluent English proficiency is mandated
- IT Literacy :Professional knowledge of MS-Office
