Job Description

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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 opportunity 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.