Experience

• 

  Ziska Pharmaceuticals Limited

  • Bangladesh
  • Pharmaceutical Manufacturing
  • 500 - 600 Employee

  • Senior Executive, Drug Regulatory affairs

    • Jan 2023 - Present

    I served Ziska Pharmaceutical limited company as Sr. Executive, Drug Regulatory Affairs & do the following responsibilities: - Prepare all necessary & supporting documents for submitting to Directorate General of Drug Administration (DGDA), Drug Testing Laboratories (DTL). - Submit Dossier of Biosimilar Products & Take necessary steps for approval of respective Product. - Submit recipe, inclusion paper, stability data & annexure to DGDA for registration of new product. - Arrange inspection by DGDAs & narcotics in coordination with the respective department. - Take necessary steps to product renewal, annexure amendment, product specification change, pack size change etc. - I also acting supportive work In Commercial Department like as Online Blocklist submitting & approval, Drug Clearance. - Pursue and take necessary steps for obtaining drug manufacturing license and depo license from DGDA and its renewal on time. - Submit product price to DGDA for approval price and re-fixation price. - Pursue and obtain for import product registration and its renewal on time. - Supervision of drug regulatory affairs that relates to DGDA, Drug Testing Laboratories (DTL) and Department of Narcotics etc. - Communicate & coordinate with other departments like- PMD, Production, QA&QC, PD, Engineering, Commercial, Accounts, Administration etc. - New products information obtained from the DGDA. - Production Statement to Drug Administration. - Maintain Relation with key personnel Of Drug Administration & Drug Testing Laboratory.

  • Executive, Drug Regulatory Affairs

    • Jan 2018 - Dec 2022

    I served Ziska Pharmaceutical limited company as Executive, Drug Regulatory Affairs & do the following responsibilities: - Prepare all necessary & supporting documents for submitting to Directorate General of Drug Administration (DGDA), Drug Testing Laboratories (DTL). - I also acting supportive work In Commercial Department like as Online Blocklist submitting & approval, Drug Clearance. - Submit recipe, inclusion paper, stability data & annexure to DGDA for registration of new product. - Arrange inspection by DGDAs & narcotics in coordination with the respective department. - Take necessary steps to product renewal, annexure amendment, product specification change, pack size change etc. - Pursue and take necessary steps for obtaining drug manufacturing license and whole sales drug license for sales depot from DGDA and its renewal on time. - Submit product price to DGDA for approval price and re-fixation price. - Pursue and obtain for import product registration and its renewal on time. - Supervision of drug regulatory affairs that relates to DGDA, Drug Testing Laboratories (DTL) and Department of Narcotics etc. - Communicate & coordinate with other departments like- PMD, Production, QA&QC, PD, Engineering, Commercial, Accounts, Administration etc. - New products information obtained from the DGDA. - Production Statement to Drug Administration.

• 

  Marksman pharmaceuticals ltd

  • Dhaka, Bangladesh

  • Executive, Drug Regulatory Affairs

    • Aug 2013 - Jan 2018
    • Dhaka, Bangladesh

    I served Marksman Pharmaceutical limited company as Executive, DRA & Commercial Department & do the following responsibilities: - Prepare Procurement budget monthly, half yearly & yearly, purchase approval sheet and receive approval from respective authorities. - Quotation collection from different suppliers. - Provide purchase order and monitoring vendors until delivery of the materials. - MRR (Manufacturing Readiness Review) collection (Raw & Packaging material) rom factory. - Developing new source for Raw , Packaging & Promotional materials. - Monitor & plan for static & near expiry material. - Prepare material delivery planning to cut the inventory cost and also to avoid the shortages. - Arrange forecast from marketing and convert the forecast to demand plan. - Create alternate plan for critical Raw & Packaging materials. - Monitor L/C, customs clearance & assessment process from abroad. - Ensure raw and packaging materials stock planning as per inventory norms. - Monitor and maintain safety stock for Finished Goods, Raw & Packaging Materials. - Update vendor database regularly basis. - Prepare all necessary & supporting documents for submitting to DGDA & DTL. - Submit recipe, inclusion paper, stability data to DGDA for registration of new product. - Arrange inspection by DGDA in coordination with the respective department. - Take necessary steps to product renewal, annexure amendment, product specification change, pack size change etc. - Pursue for obtaining drug manufacturing license and depo license from DGDA and its renewal on time. - Prepare new block list as well as amendment approval from DGDA & also drug clearance. - Submit price & re-fixation price to DGDA for approval. - Supervision of drug regulatory affairs that relates to DGDA, DTL. - Communicate & coordinate with other departments like- PMD, Production, QA&QC, PD etc. - Maintain Relation with key personnel Of DGDA & DTL.

• 

  Sanofi

  • 6/2/A segun bagicha dhaka.

  • Medical Information associate

    • Nov 2012 - Jul 2013
    • 6/2/A segun bagicha dhaka.

    I served Sanofi-Aventis Bangladesh limited as MIA in Cardiometabolic team and do the following responsibilities: 1.Visit doctors & promote my product & earn prescription. 2. Visit key personnel of Govt. & Non-govt. institutions to achieve the target . 3. Achieve the target.

• 

  Biopharma Limited

  • Dhaka, Bangladesh

  • Medical Associate

    • Oct 2011 - Oct 2012
    • Dhaka, Bangladesh

    I served Biopharma limited as Medical Associate in Chronic Care (Cardiac & Diabetic product) team and do the following responsibilities : 1.Visit doctors & promote my product. 2.Earn prescription.