Overall in-charge of IVD regulatory activities for South Asian markets majorly India involving- New Drug applications- Sample testing of critical diagnostic kits- Additional label(s) fixed at warehouse- Reviewing published literature, marketing promotional documents of a product- Import and Export consignment clearance by the AirportsCoordinating arm between company for regular interactions and technical discussions with various regulatory agencies such as CDSCO, National Institute of Biologicals (NIB).- Maintaining records for dossiers and approvals at proprietary - internal share point, while coordinating with QIAGEN Germany.- Overall reporting to QIAGEN in India and United States

• Ensure the timely filing of new applications or response to queries in order to get approvals from various regulatory bodies i.e. DCGI, DGFT, FSSAI, DBT etc.• Prescreening of all the fillings/dossiers of marketing authorization under Form-44 and preparation of applications/dossiers like import & registration, export, Form-29, Form-11 as per checklist issued by CDSCO, before submission and also ensuring the reduction of repeated queries and clearance of file smoothly.• Keeping constant track of file movements and follow up of various applications filed at DCGI, FSSAI, DGFT & DBT.• Filling application for testing of New Drugs samples at Indian Pharamacopoeia Commission, (MoH&FW) Ghaziabad.• Preparing, and sharing of fortnightly status report for Delhi corporate office with senior management and MIS preparation on monthly basis, for final presenting to senior management.• To maintain the stamp fee for budget and raise an alarm quarterly to HO-BD team, if it increases beyond allocation.• To check and ensure the timely sharing of the various financial statements (cash/bank statements) with HO team.• To build and maintain the relationship with officials of various regulatory bodies i.e. DCGI, FSSAI, DBT, DGFT, as a part of image building activities for the Organization and to get the timely approvals.• Regular interaction and technical discussion with various regulatory bodies to be diligently followed, for smooth sailing of approval process.• To collaborate effectively with internal GPL & GGL stakeholders (i.e. GRA/BD/PMT/Medical/ Clinical/R&D Teams)• Having good relationship at IGI, Airport cargo, New Delhi for the clearance of consignments. • Preparation and maintaining of SoPs related to various applications filed at DCGI (like Import & Registration, Form-29, Export Permission, Form-11 etc)

Working at the post of Technical Data Assoaciates. Expertises in New Drug/SND/FDC/Vaccine & Biologicals/Medical Devices/ Diagnostics/Cosmetics.

To increase the sale of various brands of Raptakos & Brett Co. ltd. by doing market research and also by visting to various customers (Chemist shops, Wholesalers, Doctors etc)

In process testing of smaples and Quality Control of various batches manufactured at the site. Also mataining the STPs anf various inventory of reagent of the Quality control Division.

Dispensing and Taking care of inventory of Medicines.

Pharmacist job at field as well as different sites for one year