To support the development and execution of regulatory strategies for NCE projects including 505 b 2 pathways To prepare compile and review IND NDA ANDA and MAA dossiers in eCTD format To coordinate timely submission of regulatory documents to CDSCO and global health authorities To ensure all submissions comply with ICH USFDA EMA CDSCO and other applicable guidelines To assist in preparing responses to regulatory queries deficiency letters and follow up requirements To coordinate communication with CDSCO global agencies and partner affiliates under supervision To support the arrangement and documentation of regulatory meetings and discussions with authorities To track updates in regulatory requirements and communicate relevant changes to stakeholders To ensure adherence to GxP pharmacovigilance norms and internal compliance processes To assist in audit preparation and support during regulatory inspections To collaborate with R D Clinical CMC Quality and Commercial teams for regulatory inputs To support documentation and submissions related to clinical trial applications and product development To conduct regulatory intelligence and compile summaries on global guideline changes and competitor activity To maintain regulatory documentation submission trackers and archives for assigned projects To support senior regulatory team members and contribute to standardization and process improvements M Pharm Amneal is an equal prospect employer We do not discriminate based on caste religion gender disability or any other legally protected status We believe in fostering a workplace that values diversity and inclusion

📌 Deputy Manager, Regulatory Affairs | Nce | Cdsco And Global Regulatory Agencies (Gujarat)
🏢 Amneal Pharmaceuticals
📍 Gujarat