
Assistant Manager
2 days ago
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.
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