Jr.Executive/Executive - Regulatory Affairs

Roles and Responsibilities 1) To prepare dossiers for product registration, renewal and variation applications in African, Middle East countries ROW Countries in Regional as well as CTD formats as per the requirements for registration purpose. 2) To check artworks for regulated/ semi regulated countries. 3) To co-ordinate for documents and samples for regulatory submissions with manufacturing locations LL & 3rd party manufacturing 4) Handling of queries pertaining to regulatory submissions from various regulatory authorities. 5) Maintain and update regulatory archives and Regulatory Database of the identified countries. 6) Any other work assigned by Regulatory Head/Technical Head as required 7) Handling specific Projects like New products/ SOPs etc.