Global Regulatory Submissions.Handled a team of CMC post approval life cycle submissions for a multinational pharmacetuical companies - Drug Product Renewal, Annual Updates, Amendments, Variations - across all countries.

Prepared / Authored submissions for small molecules, marketed products (Drug Product Dossiers / DMFs). Handled several submissions for drug product registrations, including CMC dossier writing for new submissions and post approval variations. Regulatory affairs CMC expertise in CTAs/ IND/ IMPDs/ NDA/ MAA / DMF for all markets (EU/ US / ROW) and their supplements/ amendments/ HA response, US annual reports, EU renewals there on. Expertise in reviewing registration documents in identifying gaps by performing gap analysis and gap closure. Regulatory project management, strategy and implementation of changes closure to the outcome.

- Successful in filing several API / DS intemediates DMFs (sterile and non-sterile APIs) to US FDA- Successful in filing Certificate of Suitability with EDQM and contributed significantly in getting faster approvals.- Successful in filing several DMFs (Open & Closed part's) to regulatory authorities in Europe, Canada, Korea and DMFs in most of the countries as per the business need.

Responsible for Review, Preparation, Customization and Submission of Drug Master Files (DMFs) [CTD] to EDQM.Data collection and Review of documents required for DMF/CTD preparations (viz. Analytical Reports, Process Validation Reports and BMR/BPRs, Protocols).Involving in QA activities such as preparation of SOP’s, BMR and Site Master Files.Worked with R&D Head in conducting R&D trials for new products and process development for existing products.

Export country, new product registration, including preparation / customization of dossier, submission, correspondence and follow-up and also coordinating export country registration in different South East Asian countries including Nepal, Bangladesh and CIS countries and also provided free product samples for the same.Responsible for maintaining all regulatory documentation in compliance with country regulations and company procedures.Submission for the issue of Registration Certificate for import of drugs into India under Drugs and Cosmetics Rule, 1945, Form 40 to Drugs Controller General of India, Delhi [Rule G.S.R. 604(E), w.e.f Jan, 2003] for New products and as well for Existing products.Preparation and submission of all documents for Manufacturing licenses/authorization, FSC, GMP, Performance Certificates (for Govt. tender business participation), Loan Licences, Additional Product Licences, Import licence, Test licences and NOC to Drug Control Administration (DCA), Hyderabad, FDA and import Licences, test licences DCGI for New products and as well for Renewal of licences and followup to closure of outcome.Licensed to import of Finished Goods in Livestock veterinary & Poultry products and also for both Domestic & Export Market.Coordinating correspondence with Trademark attorneys for Trademark search reports for trademark availability, filing trademark, legal issues and New Trademark development for marketing uses.Handled Biologics dossiersHandling labeling materials (cartons/leaflets/labels) and promotional materials coordinated FDA product registration requirements and supported sales and marketing.

Preparation of Master Product Manuals, In-process records, Specifications (In-process, Finished products & Raw Material) for various pharmaceutical dosage forms. Preparation of licensing information (label/carton/leaflets information & composition details etc.) for submitting to regulatory authorities for various pharmaceutical dosage forms & Developed Formats for regulatory use.Maintenance of high priority and confidential documents electronically by using Documentation Management System Software in Dr. Reddy’s Laboratories Ltd.Files maintenance (Like Correspondence files, Product files, Product Dossiers etc.,)Searching patents information in Internet about the products like prescribing information, stability of the product, storage conditions, and reactivity. Competitor products information.SAP: Master codes & online entry of Bill of Materials (BOM) creation. Raising indents for materials procurement (Requisitions & Reservations). Maintaining Requisitions Numbers for follow up with purchasing department.