Overall 17 years’ Experience in the field of International Regulatory Affairs from well-known pharmaceutical companies in various Pharmaceutical preparations like Solid Orals, Liquids, Parenterals- Liquid/Dry Powders/SVP/LVP/Lyophilized, Complex products, Topical and Ophthalmic Preparations, Dermatological, Medical Devices etc. Markets: Emerging- South Africa, MENA, IC, US, EU, Canada, Australia and Japan• Assessing regulatory acceptance of new initiatives or new technologies • Defining and executing regulatory strategies for the filling • Streamlining product registration and approval process• Influencing/Shaping a positive internal and external regulatory environment• Providing strategic counsel to balance organization on product registration/regulatory issues• Leading team for preparation of dossiers for submissions to approvals • Support and guidance to cross functional teams of R&d, API and Plants • Liaisoning with overseas team for planning and submission activities• Liaisoning with third party manufacturers for documents and samples• Liaisoning with contract laboratories for contract studies• Review of adequacy of dossier as per eCTD/ACTD/country specific regulations• Response to queries raised by the Regulatory Authorities• Response to technical queries of the Notified Bodies and customers/consultants• Change control approval and management of variation• Management of life cycle portfolio