Regulatory Manager

Role Overview: As a Regulatory Affairs professional in a biotech/biopharma company, your role will involve having a strong knowledge of the drugs and cosmetics act, GMP, Schedule M, and extensive experience working with regulatory bodies such as CDSCO, Local FDA, DCGI, and RCGM. You will be responsible for facing multiple audits by these agencies and handling various types of applications including animal studies, clinical trials, marketing authorizations, manufacturing licenses, export and import licenses, and GMP certification. Key Responsibilities: - Demonstrate knowledge of drugs and cosmetics act - Ensure GMP and Schedule M compliance - Work closely with CDSCO, Local FDA, DCGI, RCGM - Manage and face audits by regulatory agencies - File applications for animal studies, clinical trials, marketing authorizations, manufacturing licenses, export and import licenses, and GMP certification - Build and maintain personal rapport in DCGI Qualifications Required: - Previous experience working in CSSCO or DCGI is preferred Additional Company Details: The company is seeking candidates with extensive knowledge of regulatory affairs, experience with audits and compliance, and the ability to establish personal rapport in DCGI. Previous experience in CSSCO or DCGI is considered a plus.,