Job Description
Objective: Ensuring the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products. Main Responsibilities : • Act as the Company Responsible Pharmacist and ensure that all regulatory affairs roles and responsibilities are carried according to MoH requirements. • Timely registration submissions of new products to enable launch. • Ensuring existing registrations and licenses are maintained and updated / renewed timely. • Ensure timely implementation of labeling requirements; proof-read labeling items and updating timely specific labeling materials • Ensure regulatory compliance in product shipments, promotional materials review and product importations authorization • Responsible for coordinating and leading local GMP ,FSC,PIAF,…and other external inspections. • Acts as safety responsible person by corrective & preventive actions. • Responsible for products nonconformity Process and testing. • Verification customers Claims and Doing corrective actions. • Preparing related SOP’s for regulatory process. • Following up Process in MoH and related Organizations • Analysis Products Facts and updated scientific research about Health and Supplements. • Preparing Business driven information base on scientific Researches. • Market Study and comparison our product vs other competitors. Reporting to : Managing Director Desired start date : As soon as possible Working hours : Half-time
Requirements
University qualifications : Pharmacist Other certifications : Have Technical Responsible Certification for MoH Previous experience : +3 years of experience in Regulatory Affairs in Pharmaceutical Companies. Experienced in Brand registration from A-Z Specialist knowledge : Brand Registration Process. MoH regulations and process Food, Pharmaceutical & sport Supplements. Supplements Advantage and disadvantage. Regulatory affairs certification like GMP, PIAF &… Medical & Pharmaceutical Business Competitors product analysis Other Skills : Eager to Design & run regulatory affairs process in a new established company. Good communication skills Time management High attention to details and accuracy High commitment Customer Oriented Eager to Learning & Researches. Business oriented Pro-active Self-Control Expert in :Excel & Word & Presentation Language Skills : English Current Residence : Tehran
Employment Type
Seniority
Details
Employment type
Educations
Seniority

