Manager - Corporate Regulatory Affairs

Job Description Preparation of registration strategy for various health authorities like Brazil and other Latin American countries i.e. Peru, Ecuador, Colombia, Panama Adequate understanding on Brazil guidance and filing of new product and post approval changes Review of documents related to product registration and dossier submission leading to faster approval Prepare response to deficiency letter received from various agencies Maintain life-cycle / post approval changes for drug product registration dossiers including timely circulation of approval information Provide regulatory support to cross functional department Adequate assessment of change control as per regulatory guidance Prepare and submit scientific advice to various health authorities Compilation, verification and submission through electronic gateway