Manager

JOB RESPONSIBILITIES Major purpose of the Job : •Define and execute regulatory strategies for pre and post-approval supplements for US market. •Drive regulatory strategies and ensure timely approvals to support business objectives. •Handling of regulatory Labelling/artwork review and submission. •Mentor the team in submission planning, eCTD management, labeling compliance, and regulatory intelligence. •Handling of Pre approval activities including ANDA/BLA/IND/NDA/Orphan drugs submission. •Review and handling of regulatory Labelling/artwork, NDC codes, SPL related activities. •Review and finalise the Post approval activities: Annual Reports, Supplements (CBE-0, CBE-30, PAS, RLD update, Safety Labeling change). •eCTD software handling for new submissions, query responses and post approval submissions.•Review and approval of site documents such as process validation protocol, process validation report, BMR and BPR etc. •Review and approval of Change Controls & Deviations, MMD-II, fert code, and MDM release. •Help team for creation and maintenance of Regulatory Database for all the submissions. •Tracking of Regulatory Guidance Documents at the respective websites.