Job Description

Responsible pharmacist for regulatory affairs will coordinate and document regulatory processes, such as registrations, license renewals, and audits and act as a link between the company and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation. The main responsibilities are as follows: - Develop and register the new formula and product in the market - Able to work under pressure and tight deadline - Familiar with dossier and CTD format - Be familiar with the international pharmaceutical guidelines and pharmacopoeia - High standards of accuracy and professionalism - Timely registration submissions of new products to enable launches as planned locally - Ensure existing registrations and licenses are maintained and updated / renewed timely according to local requirements and internal NN processes - Follow up and ensure the implementation of local Regulatory Intelligence and health authorities' requirements for Iran - Ensure timely implementation of labeling requirements; proof-read labeling items and updating timely all country specific labeling materials - Ensure regulatory compliance in product shipments, promotional materials review and product importations authorization