Senior Regulatory Affairs Specialist

Job Title: Asst.

Manager – RegistrationPurpose of the Job:Responsible for the timely registration of PSI products in local & export markets.Registration actions/activities for the APIs (Active Pharmaceutical Ingredients), excipients, and packaging materials.MAIN DUTIES AND RESPONSIBILITIESManage electronic submission of Registration Files in eCTD format to SFDA and other regulatory authorities (outside KSA)Review the data in the registration files prepared for submission to the regulatory authorities.Life cycle management (registration, renewal, variation) of PSI products according to SFDA & Export countries’ regulations.Keep the registration archive complete (maintain and update the status of registration, renewal, and variation) and ensure that all licenses and labeling are up to date.Check the applications for the SFDA market on the eSDR site.Coordinate and follow up with the concerned departments like Q.C, Q.A., Production, and R&D for the collection of various data.Manage reviewing and responding to all documents relating to APIs/excipients and packaging materials (like the open part of API CTD) and related documents in both Change Control Proposals (CCPs) & Supplier Notification System Forms (SNSFs).Provide responses to queries and comments raised by SFDA & other regulatory authorities.Keep abreast of international legislation, guidelines, and customer practices in all countries that the company is exporting to.Represent regulatory affairs on the R&D product development project team to ensure that all regulatory requirements are met throughout the development process.Education:Bachelor’s degree in Science or PharmacyExperience:5 years in Regulatory activities in pharma companies.