Job Description
Responsible Pharmacist for Medical Devices Regulatory Affairs: ● Following and being updated on the local regulations and health authorities’ requirements. ● Updating the company and related departments with the latest regulations of MOH (Ministry of Health). ● Updating regulatory data sheets and reporting them on regular bases. ● Coordinating with foreign companies and local manufacturing sites to obtain necessary documents. ● Providing SOPs and implementing pharmacovigilance based on PV guidelines. ● Reviewing the CTDs contents and preparing them for MOH review. ● Product registration, license renewal, and variation submission. ● Visiting MOH persons regularly to follow up on pending tasks with them. ● Following all the companies' activities in MOH properly and regularly.
Requirements
● Pharmacist (PharmD). ● Preferably 5 years of experience in regulatory affairs of pharmaceutical products. ● Good understanding of the relevant Iranian MOH and quality framework. ● Familiar with IDL and brand registration. ● Familiar with Dossier and CTD. ● Familiar with the procedure of TTAC. ● Familiar with pharmacovigilance guidelines. ● Good knowledge of English, written and spoken. ● Proficient in Word, Excel, and Outlook. ● Excellent in interpersonal relations, flexibility and adaptability, self-motivation, loyalty, and well-recognizing. ● Strong analytical skills, data-oriented, hardworking, and team worker. ● Familiar with importation, contract, and under-license manufacturing process and regulations.
Employment Type
- Full Time
Job Category
Seniority
Details
Employment type
- Full Time
Job Category
Educations
Seniority
