Regulatory Affairs

Should have experince & exposre to handle all global reg fillings such as USFDA, EDQM and other European countries, Japan, Australia, Canada, WHO and other semi regulated markets like Brazil,  China and others.
-  To handle of overall regulatory activities starting from product development to approval and subsequent
change implementations for all Reg, Semi Reg, Immerging and Non-Reg / domestic market.
-   To showcase excellent aptitude in managing manpower and Customers.
-  Co-ordination & Communication with all functions for all respective activities of regulatory.
-  To Involve in technology transfer meetings to have awareness on regulatory submission for all types of products.
-  Responsible for Managing the global regulatory submissions, designing and executing the regulatory strategies for products submissions
-  Post-approval/variations activities, securing approvals and maintaining compliance of approved
applications (Life Cycle Management)
-  To handle Product lifecycle management for global market
-  To partipiate in all development activities starting from review of Technology transfer documents, Pharmacopeial Compliance, Limit finalization of all imps, finalization of specification, Idetification & evaluation of Genotoxic, Nitrosos, Azido impurities and establish their control strategy....etc as per the regulatory requirements (To develop regulatory strategies during product development)
-  To hanlde Change cotrols, customer complaints and techno commercial activities.
-  To ensure all types of regulatory compliance
-  To ensure & handle vendor qualifications to customers and vendor approvals and other plant related activities like OOS, OOT, Deviation..etc with respect to regulatory submition.
-  To ensure Reg
-  To generate Electronic submission Gateway (ESG) and Common submission platform (CESG) required for various regulatory submissions.
-  To establish future proof tracking mechanism to track various documents provided to different customers.
-  Strategic Planning for preparing, coordinating, evaluating and submission of regulatory dossiers
(Drug Master Files) to various authorities.
-  To take a lead in evoluation, Summarize, track and to respond the received Reg deficiencies from various agencies and co-ordination with cross functional departments for submission of responses within the timelines.
- To evaluate and categorize the changes by regulatory prospective and ensure the relevant notification to customers and regulatory amendments/revisions to various health authorities in a timely manner.
- To Involve in various day to day quality activities to improve the system of the organization
-  To train the CFT team to have awarness, knowledge with respect to current guidelines and regulatory requirements
-  To take frontline responsibility during the preparation of regulatory audits from regulatory prospective
-  Any other activiites falls under Regulatory affairs.