Responsible for Regulatory function for NDDD projects.

• Regulatory Activities for New Drug Development Projects.-Preparation of complete dossiers for Regulatory Submissions to conduct Clinical Trials for New Molecular Entities(NMEs). Successfully compiled dossiers for Phase I and multi-country Phase II Clinical Trial applications for countries like The Netherlands, UK, India, Australia, USA, Poland, Czech Republic, Sri Lanka, Philippines and Russia.-Preparing CMC section for all the Clinical Trial Applications for NCEs.-Working on Regulatory Strategy for development of new molecules • Creation and maintenance of extranet site for regulatory submissions and keeping track on various regulatory obligations.• Coordination for QP release of IMP supplies for used in Clinical trials in the Europe.• Applications for Export/Import/Test & trial(Form 29) of Bulk actives/Finished products to DCGI/state FDAs in India• Coordination for QP release of IMPs for use in clinical trials in EuropeEarlier assignments • Project Management for various programs.- Project management for Pre-clinical studies and planning and support conduct of Phase I and Phase II clinical Trials.-Project Cost Management; Budgeting, cost tracking and cost control-Identification of critical issues and potential risks delaying the project schedules and generation of back-up mitigation plans.-CRO Management, Risk Management and Logistics Management-Technical Coordination and discussions with Study Directors across Global CRO’s.-Material management for all in-house and external GLP studies• Alliance Management -Interacted with partners for out-licensed molecules, managing supplies of API, Formulations, Intermediates, reference standards etc as and when required, exchange of data (like regulatory submissions, final study reports and discussions on queries between the licensed partners.• Achievements-Managed two Discovery Projects which lead to out-licensing deals

Worked with Fulford (India) Limited, a subsidiary of Schering Plough, USA now Merck & Co. Inc, USA• Preparation of New Drug Application dossier for submission to DCG(I) for marketing authorization in India. (As per schedule Y), • Co-ordinating with different centres for clinical studies. Clinical supply management. Judicious monitoring of clinical trial budgets. Support to the Medical Director for Pharmacovigilance reporting and training.• Providing key information related to the company products and new products to the Marketing Team. • Co-ordinating with editorial board members for timely publication of What’s New in Dermatology, a esteemed journal, published by Fulford. • Updating Package Inserts to keep them aligned to international labeling revisions and submission to DCGI.

• Performing animal pharmacology studies on proprietory ayurvedic formulations. • Coordinating with centres for clinical trials on ayurvedic formulation. • Compilation of technical information for different plants. • Conducting clinical pharmacology studies by Laser Doppler Velocimetry for topical products.

• Operating instruments like NMR, GC-MS, Elemental Analyser, HPLC etc. • Analysis of FDA samples in the Lab• Literature Search and providing information from MEDLINE / IPA / DIF on CD on analytical information required for method of development of generic products to Bioequivalence department.

• Planning of Production and co-ordination between Sales, Purchase, Quality Control and Production Departments. • Preparation of documents for FDA Licences, • Preparation of Product Record Cards.

• Worked as apprentice in various departments like Tablets, Capsules, Liquids, Suppositories, Injections, Creams and Gel formulations. Have also worked in the Stores department.• Involved in computerization of documentation in all the above departments for activities like Batch Records, Reports, Stock Statements, etc.