Experience

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  Synbiotic limited

  Jun 2008 - Jul 2009

  Qa

  • Responsible for preparation of SOP, SMF, VALIDATION PROTOCOL• Reviewing DMF

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  Alembic

  Jun 2011 - Jul 2012

  Project managment r&d

  • Tracking of formulation Projects as per its given timelines; monitor it throughout the project and periodical internal review, monthly reports.• Regular coordination with respective departments for smooth and timely lab scale development. • Coordinate with Purchase Dept. and ensure procurement of API & Excipients.• Coordinating with various departments QA, QC, Production, F&D and Packaging for technical data and document required for dossier.• Coordinating with BE department for protocol preparation and scheduling for the BE studies also Tracking for availability of Investigational products and its report timelines.nsure various clearances (License application, BENOC application and innovator application) and certifications from Regulatory bodies and other agencies for development projects and also ensure timely submission of all dossiers from RA department. Show less

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  Oman pharmaceutical products co llc

  Nov 2012 - Feb 2016

  Regulatory affairs

  • Responsible for preparation and submission of dossiers in MENA countries, ASEAN markets and other ROW countries (Oman, GCC, Philippines, Myanmar, Vietnam, Srilanka, Cambodia, Singapore, Afghanistan, Saudi Arabia, Jordan, Iraq, UAE, Azerbaijan and West Africa)• Preparation, compilation, publishing and validation of documents in NEES/eCTD.• Preparation of dossier in CTD/ACTD format as per market requirement.• Checking of dossiers/ Artworks/technical documents received from plant and other organizations.• Review of stability data protocol based on stability specification.• Review of Release and shelf life specification as received from QA before submission.• Review of In-process testing parameters, analytical methods and specifications used for testing.• Review of Clinical documents.• Response to various regulatory queries received from various regulatory agencies in coordination with plant R&D & ADL.• Coordination with various regulatory agencies to fasten the procedures as an when required by customer.• Collaborate with QA for availability of documents.• Planning of dossiers and to be ready for submission on request • Responsible for maintaining record of Dossiers / query throughout the registration cycle.• Preparation and submission of Samples• Indenting of reference standard, Innovator samples and other QC lab requirements as per request. Show less

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  Vimpex limited

  Sept 2016 - Sept 2018

  Manager regulatory affair

  • Coordinating with different principals for timely availability of registration samples and documents for Food, Drug, Cosmetic and medical device.• Responsible for effective and quick submission of samples and dossiers to FDA• Checking of dossiers documents and samples.• To keep track of the regulatory process & requirements and to coordinate with concerned Country managers and other principal executives.• Tracking for registration fee and other charges.• Responsible for raising Debit note for registration fees to the Principal and its tracking for timely availability of payments.• Informing renewal registration and submission in time to principal• Coordinating and arranging documents for import permit and DIAC attachments• To keep record all documents incoming and outgoing • Informing and reporting regulatory update and status internally and externally.• Making and developing new relationships with new customers.• Selection of products for Myanmar market.• Negotiating price and registration requirements.• Reviewing of Agreements and commenting on the same.• Meeting up new customer for Business.• Providing regular updates on new business development with customers and also ongoing Regulatory status. Show less

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  Drn international limited (registration consultant)

  Sept 2018 - now

  Founder/director

  DRN International limited is a registered company in Myanmar which was incorporated under Myanmar companies law 2018 on 12.09.2018.We are Drug registration consultant looking after registration of Pharmaceutical products with FDA Myanmar."Warmly Welcome all for your product registration in Myanmar-FDA"