Regulatory Affairs Specialist

Job Description

Deadline for application: March 5th The position As a regulatory affair specialist, you will be responsible for supporting the coordination of Regulatory Affairs applications related to product Life Cycle Management (LCM) and/or New Drug Approvals (NDA) in Iran. Managing the compiling, submission and approval activities for New Drug Application (NDA) and Life Cycle Management (LCM) licenses under supervision of RA Manager. • Assist RA on monitoring the regulatory environment and ensure compliance • Provide information on local regulatory requirements to other departments • Draft routine correspondence to FDO concerning import, release and distribution permissions • Manage compiling, coordinate and supervise Regulatory Affairs applications related to NDA and LCM • Assess registration files, ensuring adequate follow-up with regulatory • Review the list for documents required for submission and provide on time product information as required • Provide regulatory support and insight to key stakeholders and RA Manager • Establish and maintain fluent and open interaction and cooperation with other departments (Quality, Marketing, Legal, Logistics, medical and HAs) • Maintain an open and fluent communication flow with different external stakeholders, preparing routine correspondence with regulatory HAs and being ready to answer their questions during the submission and approval of NDA and LCM license