General Manager - Regulatory Affairs

Job Description

· To initiate and consult scientific advice with respective territory agents, partners or concerned MOH regarding submission strategies, submission requirements and other key administrative aspects related to regulatory process and effective implementation of meeting outcome within the organization. · To prepare and ensure deliverables for initial registrations, renewals, re-registrations and or post approval changes required in technical dossiers or client data package for drug products of regulated and ROW markets. · To handle dossier due-diligence activity with territory business partner (s), MOH queries, finalization of response action items, coordination with stakeholders, collation of response dossier and submissions of data package containing query response to MOH through appointed partners or service provider within stipulated timeframe. · Adequacy, accuracy, completeness and compliance check of dossier documents, registration dossiers, query responses, variation package and renewal dossiers before its submission. · To schedule trainings or discussions regarding new or revised agency guidelines within team and with concerned stakeholder's site. · To collaborate with internal and external stakeholders for organizing dossier document as per checklist, finalization of timelines to receipt dossier related data, administrative documentations and information's relevant to submission batches or post approval commitments. · To participate in dossier due-diligence process and resolve client queries on technical dossier and finalization of registration dossier within stipulated timeframe. · To prepare internal regulatory strategy position paper and organize scientific advice meeting with MOH or with territory business partners during product development (when applicable). · Effective management of DRF process and prioritization of dossier submission for products having approved DRFs for EU/ROW markets. · Planning, review and submission of CTD/ACTD/eCTD dossiers for export markets (Regulated and ROW countries). · Coordination with site QA regarding site registration documents for export markets (Regulated and ROW countries). · Participation in regular client meetings and ensure compliance to action items. · Coordination with Bioequivalence CRO's regarding study finalizations, study report receipts and other responsibility such as sponsor's representative at site during study monitoring for regulated market projects of critical dosage forms as an when necessary. · Review of technical documents, ODMFs, CMC, Non-clinical, Clinical and other administrative portion of technical dossier. · Follow-up with manufacturing site for registration sample(s) inclusive of API and finished products, placebo, working standard(s), impurity standards, HPLC columns and reagent those are requested by MOH for visual checks and lab analysis. · To prepare monthly regulatory report of new registration/re-registration/post approval changes. · Coordination for renewal of FDA license (Manufacturing license with product permission, free sale certificate, local GMP, WHO GMP & COPPs). · Coordination with site QA team regarding customer and MOH inspections at manufacturing site. · To train regulatory team for effective usage of man-hours, work allocation, cost reduction proposals and monitoring completion status of defined tasks. · To cadre other miscellaneous tasks falls under the framework of regulatory affairs. Show more Show less