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    Soumitra Mohanta

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    Hemant Panda
    1. Soumitra Mohanta is seeking a position and has over 10 years of experience in regulatory affairs and preparing drug dossiers for international markets. 2. He currently works as a Regulatory Affairs Officer at Healthy Life Pharma preparing dossiers and handling regulatory communications for countries in Africa, Southeast Asia, and Latin America. 3. Soumitra has a M.Pharm in Pharmaceutics and B.Pharm degree and professional skills in ICH guidelines, drug registration procedures, and technical document preparation.

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    Soumitra Mohanta

    Uploaded by

    Hemant Panda
    79 views3 pages
    1. Soumitra Mohanta is seeking a position and has over 10 years of experience in regulatory affairs and preparing drug dossiers for international markets. 2. He currently works as a Regulatory Affairs Officer at Healthy Life Pharma preparing dossiers and handling regulatory communications for countries in Africa, Southeast Asia, and Latin America. 3. Soumitra has a M.Pharm in Pharmaceutics and B.Pharm degree and professional skills in ICH guidelines, drug registration procedures, and technical document preparation.

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    1. Soumitra Mohanta is seeking a position and has over 10 years of experience in regulatory affairs and preparing drug dossiers for international markets. 2. He currently works as a Regulatory Affairs Officer at Healthy Life Pharma preparing dossiers and handling regulatory communications for countries in Africa, Southeast Asia, and Latin America. 3. Soumitra has a M.Pharm in Pharmaceutics and B.Pharm degree and professional skills in ICH guidelines, drug registration procedures, and technical document preparation.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    79 views3 pages

    Soumitra Mohanta

    Uploaded by

    Hemant Panda
    1. Soumitra Mohanta is seeking a position and has over 10 years of experience in regulatory affairs and preparing drug dossiers for international markets. 2. He currently works as a Regulatory Affairs Officer at Healthy Life Pharma preparing dossiers and handling regulatory communications for countries in Africa, Southeast Asia, and Latin America. 3. Soumitra has a M.Pharm in Pharmaceutics and B.Pharm degree and professional skills in ICH guidelines, drug registration procedures, and technical document preparation.

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    of 3

    RESUME PRESENT ADDRESS SOUMITRA MOHANTA Room no 713, Patel compound Road number-3, Khar- West Mumbai , Maharashtra-

    - 400052 Email- [email protected] Mob: +91-8108682243 -----------------------------------------------------------------------------------------------------------------------OBJECTIVE I am a dynamic and ambitious person who wants to improve knowledge, capabilities and learn from every experience & put them to use for the development of the organization. EXPERIENCE Worked in HEALTHY LIFE PHARMA PVT. LTD as Regulatory Affairs Officer. From January 2012 to till date. JOB RESPONSIBILITIES: 1. Preparation of Registration Dossiers, for Submission to various Ministry of Health of countries for ROW, ASEAN & LA markets as per the country guideline. 2. Tackle ACTD & CTD dossier format for submission to different regulatory agencies. 3. Co-ordinate with QC & QA department for preparation of documents as per Regulatory Authority requirements & format. 4. To Tackle & Draft the queries which are received from Ministry of Health of different countries 5. Co-ordinate with the manufacturing facilities for registration samples arrangement. 6. To prepare the dossier related legal documents for the submission to Drug Controller. 7. To initiate the Packaging Material art works as per guideline & Prepare Packing Insert, PIL 8. Application, review, co-ordination, follow-up of legal documents to local FDA for Mfg. License, WHO-GMP Certificates, COPP, FSC, Market Standing, etc. 9. Prepared documents for courier of samples like MSDS, No commercial invoice, etc. 10. Prepare & Review of FPCOA, RAW COA, In Process COA as per country requirements from the raw data received from the concern department. 11. Negotiating with regulatory authorities & obtain local FDA approvals for marketing authorization.

    12. Prepare, review, compile and co-ordination company registration and Tender purpose.

    of

    documents

    required

    for

    13. Reviewing manufacturing documents like MFR, BMR, Process Validation Protocol/Report, Stability Protocol/Report, COA, QC report, Packaging Material Specification, Excipients Specification , Active material specification, and Finished Product Specification. 14. Proper monitoring and maintenance of regulatory communications COUNTRIES HANDLED: African Countries: Uganda, Zambia, Malawi, Nigeria, Kenya, Mozambique, Ghana. South East Asia: Sri lanka, Philippines. Latin America: Peru, Paraguay, Panama, Bolivia, Dominican Republic, Venezuela, Honduras, Costa Rica, Guatemala, Trinidad & Tobago PROFESSIONAL SKILLS 1. Knowledge about ICH guidelines, CTD (Common Technical Document), ACTD, SUPAC,WHO Certification scheme, GMP, CMC, etc. 2. Sound technical skills in preparation of MFR, BMR, Process Validation Protocol/Report, Stability Protocol/Report, COA, Packaging Material Specification, Excipients Specification, Active material specification, and Finished Product Specification, MSDS, etc. 3. Knowledge of Drug Product registration procedures of different regulated countries. 4. Knowledge of Production, Quality Assurance & Documentation also. INTERNSHIP: KOPRAN PHARMACEUTICAL PVT. LTD. - As a Project Trainee (August 2010 to March 2011) Literature search Pre-Formulation study Drug Excipient compatibility study Innovator characterization Development of Prototype Trials. Optimization of process parameters. Finished product evaluation Optimization of test product with innovator Carrying out Accelerated stability study as per ICH guidelines.

    EDUCATIONAL QUALIFICATION Examination M.PHARM (PHARMACEUTICS) B.PHARM +2 science Matriculation Name of Board/University UTKAL UNIVERSITY UTKAL UNIVERSITY I.S.C I.C.S.E Year of Passing 2009-2011 2005-2009 2004 2002 % of Marks 79 % 78 % 79 % 82 %

    PERSONAL PROFILE: Date Of Birth : 4th July 1985 Status : Unmarried Gender : Male Languages Proficiency : English, Hindi, Oriya Computer Skills : MS Office Strength : Good Presenter & Negotiator, Optimist, Good Learner, Good Listener Permanent Address : A-25, Sector- 16, Rourkela-769003, Odisha.

    DECLARATION: I, hereby declare that the above information is authentic to the best of my knowledge.

    SOUMITRA MOHANTA

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