• Review the Collation of technical documents Product Registration dossiers, and product registration renewal applications, according to the regulatory requirements of Overseas and Local Regulatory Authorities for product registration using ICH – CTD and relevant guidelines.• Query Compliances to Overseas (GCC) and Local (Qatar MPH) Drug Regulatory Authority. • Review of Technical Documents with QA/QC/R&D and for any inquiry of test methods and references for activities related to… Show more • Review the Collation of technical documents Product Registration dossiers, and product registration renewal applications, according to the regulatory requirements of Overseas and Local Regulatory Authorities for product registration using ICH – CTD and relevant guidelines.• Query Compliances to Overseas (GCC) and Local (Qatar MPH) Drug Regulatory Authority. • Review of Technical Documents with QA/QC/R&D and for any inquiry of test methods and references for activities related to dossier submission.• Finalization of monthly plan and reports for product registration dossiers, renewals and other miscellaneous work.• Finalization of List of Registered products and Products for Renewal Submissions.• Initiated and finalize the packaging development of Initial (Prototype) and commercialized products• Develop and implement new project for the QMS (Quality management System) improvement• Helps in product development of generic products till their launching compaign• Prepare product portfolio and product wise brochures to help marketing team in sales of their product• Working on new project (CE) European certificate for medical device i.e. haemodialysis products Show less

• Review the Collation of technical documents Product Registration dossiers, and product registration renewal applications, according to the regulatory requirements of Overseas Regulatory Authorities for product registration using ACTD / ICH – CTD and relevant guidelines.• Query Compliances to Overseas Drug Regulatory Authority. • Review of Technical Documents with QA/QC/R&D and for any inquiry of test methods and references for activities related to dossier… Show more • Review the Collation of technical documents Product Registration dossiers, and product registration renewal applications, according to the regulatory requirements of Overseas Regulatory Authorities for product registration using ACTD / ICH – CTD and relevant guidelines.• Query Compliances to Overseas Drug Regulatory Authority. • Review of Technical Documents with QA/QC/R&D and for any inquiry of test methods and references for activities related to dossier submission.• Finalization of monthly plan and reports for product registration dossiers, renewals and other miscellaneous work.• Finalization of List of Registered products and Products for Renewal Submissions.• Coordination with International Business and finalize products to be applied for international Markets.• Preparation and Maintenance of List of Products Applied and To be Applied in the International Markets • Review of Standard Operating Procedures (SOP’s) related to drug registration processes.• Review of initial and revised packaging material artwork/insert composition for registration purpose.• Finalize and conclude the assessment of change alerts initiated by different departments.• Review and Finalize the Certificate of Pharmaceutical Products, No Objection Certificates for Samples and other Administrative Documents.• Review the relevant Samples, Artworks, Actual Packaging, Attested Administrative documents for Dossier compilation.• Initiated and finalize the packaging development of Initial (Prototype) and commercialized products• Preparation and arrangement of documents and samples as per requirement of NOC (Preparation and Signing of Requisitions)• Coordination with designated person for DRAP and other outstation works (Embassy, KCCI, MOFA & Notary Public)• Coordination and correspondence with Consulates / Embassies for Attestation of documents and other document attestation matters. Show less

• To look for new business opportunity by identifying new molecules and new products.• Development of packaging components for Regulatory and Commercial Supply• Preparation of drug registration dossiers locally and internationally.• Correspondence and communications with International regulatory agencies regarding drug registration.• Dossier planning and their submission in respective country with Export Team• Development of Dossiers and evaluation and DMF review as per… Show more • To look for new business opportunity by identifying new molecules and new products.• Development of packaging components for Regulatory and Commercial Supply• Preparation of drug registration dossiers locally and internationally.• Correspondence and communications with International regulatory agencies regarding drug registration.• Dossier planning and their submission in respective country with Export Team• Development of Dossiers and evaluation and DMF review as per need• Timely co-ordination for arrangement of technical parts from R&D• Regular updating with distributor about submission of dossiers in respective ministry• Handling of local regulatory affairs especially dossier preparation (New drug registration and renewal of registration) • Queries reply regarding our registered and under process products.• Assisted in the successful registration of products in Afghanistan, Srilanka and most of the ASEAN countries by providing & evaluating the compliance documents within the timelines.• Project based work • Arrangements of all necessary documentation regarding provision of Active and finished samples and their COAs• Issuance of COPPs and FSCs from DRAP: making and arranging related particulars to file COPP in DRAP• Arranging innovator samples active material for dissolution profile and other testing methods as per requirement• Regulatory compliance for artworks (Export + Local)• Plan, develop and review artwork as per customer need and international regulatory guidelines.• Search international regulatory guideline and protocol for exporting products in respective market• Work on enlistment of OTC products (document developing, regulatory framework study etc.)• Working on various other projects concerned with exporting of products in advanced and 1st world countries. Show less

1. Assisted in the successful registration of Fitfree 100mg & Fitfree 300mg in Philippines, by providing & evaluating the compliance documents within the timelines.2. Assisted in the successful registration of Monis 20mg in Vietnam, by providing & evaluating the compliance documents within the timelines.3. Assisted in the successful registration of Mornig Tablet, T-sartan 80mg Tablet, Loclog 75mg Tablet, Isdin Tablet, Fitfree 300mg Capsule in Myanmar, by providing & evaluating the… Show more 1. Assisted in the successful registration of Fitfree 100mg & Fitfree 300mg in Philippines, by providing & evaluating the compliance documents within the timelines.2. Assisted in the successful registration of Monis 20mg in Vietnam, by providing & evaluating the compliance documents within the timelines.3. Assisted in the successful registration of Mornig Tablet, T-sartan 80mg Tablet, Loclog 75mg Tablet, Isdin Tablet, Fitfree 300mg Capsule in Myanmar, by providing & evaluating the compliance documents within the timelines.4. Continuously arranged, evaluated & dispatched the compliance/query documents of under registration products i.e.• Philippines (16 Products)• Vietnam (1 Product)• Malaysia (8 Products)• Sri Lanka (3 Product)• Myanmar (6 Products)5. Coordinated with distributors in exporting countries during submission of dossiers in Ministry of Health and fulfilled the requirements for successful submission. 6. Coordinated with Quality Assurance/Quality Control Department for the preparation of dossiers of finalized products.7. Developed and finalized leaflets of more than 20 products on British National Formulary format.8. Helped in finalizing Smart Pack Project .9. Prepare tour plans for Philippines, Srilanka, Vietnam and Malaysia.10. Prepare By and Between agency agreements for new client and Contract renewal.11. Prepare and Maintain concerned order and shipping documents for export Order.12. Get Orders from distributors and helps logistics to dispatch that order.13. Assist client in artwork and literature designing of products.14. Make Product profile or presentation of ( Clopidogrel, Montelukast Sodium, Isosorbide-5-Mononitrate, Losartan Potassium )15. Coordinated with distributing countries on order and forecast Update16. Prepare yearly, quarterly and monthly forecast with distributor’s help in their respected countries. Show less

Responsible for producing good quality of healthy and effective medicine for patients.

Responsible and in-charge of Cephalosporin and Hormone department from manufacturing till packaging of all products.