AGM / Sr. Manager - Regulatroy Affairs

Role & responsibilities :• Reviewing, verifying, and processing of all technical documents foraccuracy before compilation or submission of dossiers as per USFDA &PEPFAR requirements.• Review and regulatory compliance of Initial ANDA Documents likeTrade dress, Q1 and Q2, bio-wavier, IIG clearance, MDD evaluation, Sizeand Shape, Elemental iron, Residual solvent, Elemental impurity andExactable and Leachable impurity, Specifications [API and Finished drugProduct), Master Formula (with respect to Bio-waiver), Stability Protocol,Labeling Information, Product development Report, Method ValidationReport, BMR and BPR etc.• Participate and represent as regulatory team in meetings (Level 1 and 2meetings) and interact with members of all development project teams toconvey regulatory requirements and develop a strategy to meet pre-assigned goals• Review and evaluation of change controls for regulatory impacts,assigning proper supplement category along with the data requirementsthrough TrackWise software.• Evaluation and good interpretation of Post approval changes.• To train newly joined (freshers) with regulatory set-up and its associatednetwork within the department along with updating them on most recentregulatory /ICH guidance.• Review and Submission of supplements like CBE, CBE-30 and PriorApproval Supplement (PAS).• Review and submission of Annual Reports (ANDAs/NDAs).• To expedite closure of review cycle of submitted ANDAs i.e Responsesto Deficiency/Queries within stipulated time frame i.e Initial filling• review comments, Discipline review letter, Information request letter,Complete response letter, Solicited and Unsolicited amendments.• Analyzing queries on submitted ANDA Designing corrective action planwith stakeholders ensuring receipt of the required documents and Reviewand submission of responses to queries within stipulated time frame.• Labeling and SPL preparation as per RLD updates or new filing for USMarket.• Well verse with eCTD and SPL software of Pharma ready solution

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