About this role
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.
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