Assistant Manager - Regulatory Affairs

Job Description

ql-editor "> Minimum Education: M. Pharmacy Technical competencies/ Professional expertise: Expert in regulatory activities like CTD dossier preparation, query solving, well worse with ICH guidelines and updated with current regulatory guidelines. Markets exp.: Predominately Africa market (Zazibona, South Africa, East Africa-Kenya, Tanzania, Ethiopia etc, FWA) Key Performance area: New Dossier Preparation and submission Gap analysis of dossier for completion Compilation of dossier in eCTD for submission to Various regulatory authorities Coordinate submission of dossiers in various countries Query Evaluation and Submission Receipt of the query letters from the respective country team Co-ordination with the manufacturer for the query response Review of the query response received from the manufacturer. Final compilation of query response and roll out to the respective countries Ensuring the deadlines. Post approval -lifecycle management of product (Variation) Receipt of the variation / renewal package from FPP manufacturer/ or initiation of variation from Innovata s end. Review of the variation package as per the variation guidelines of the respective country guidelines Co-ordination with the manufacturer. Final compilation of the variation package and roll out to respective countries Strictly monitoring harmonisation of dossier/queries/variation across all countries. Artworks Development of artworks and approval as SOP for queries and variations as applicable. Daily Communication Communication with internal (BD, marketing, logistics, legal, designing, country RA teams etc depts.) and external stake holders (manufacturing suppliers, country agents, vendors, consultants etc ). Updating of the trackers Updating of the trackers of queries and variations on regular basis Miscellaneous Attending unit and regional meetings, trainings, meetings with the manufacturers, telecons (internal and external stakeholders) Attending trainings identified by line manager organised by Intellectus Campus.