Assistant Manager - Regulatory Affairs

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.