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Satheesh Mutya CV

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Satheesh Muthya
Satheesh Muthya

Satheesh Kumar Mutya has over 5 years of experience in regulatory affairs and business development. He has expertise in regulatory submissions, drug licensing, and acquaintances with electronic regulatory documentation standards. He is currently pursuing a PhD and has experience preparing regulatory dossiers and documentation for drug registrations in ICH and various other formats.

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SATHEESH KUMAR MUTYA SUMMARY A dynamic professional with 3.9 Years of experience in Regulatory Affairs and 1.7 years of experience in Business Development. Expertise in Literature search, Data presentation, ICH Guidelines, Regulatory submissions, Drug licensing and Acquaintance with Electronic regulatory documentation standards. WORK EXPERIENCE Spansules Formulations Since Nov 2010 as Sr. Executive Regulatory Affairs Regulatory documentation: Preparation and review of Applicant and Restricted parts of DMF (Drug Master Files) / Dossiers for drug registration in ICH, ACTD (Common Technical Document) formats in particular, the documents required for Module 3 and NeeS. Dossiers in accordance with the guidance from various Authorities viz EMA, GCC, SFDA, TGA, WHO etc. Knowledge on Granularity of document annexed by ICH for Organization of CTD. Understanding on e CTD with Module 1 regional XML DTD (Document type definition), XSD (XML schema definition), Study tagging files, md5 checksums header, style sheets and linking in XML. Consistently working with GDP (Good Documentation Practice) and in touch with Annual Reports and Amendments published by DGFT, DCGI and Pharmatimes etc. Review and verification of documents in pursuant to Chemistry, Manufacture and Control (CMC) of drug product in regulatory perspective viz Technical information files, Product development reports (CDSCO draft guidance, ICH Q8) / BCS (Bio Pharma Classification System) classes; Particle or pellet size reports, (Micronization / Statistical interpretations); Pharmacopoeia monographs, comparative analyses and CAPA reports; Analytical methods and validation (USP1225) or verification (USP1226); Labeling aspects; Stability protocols and reports, SUPAC (Scale up post approval changes); Material safety data sheets and Documentation exhibits; Confidential Disclosure Agreements / Indemnification agreements.
Licensing Export NOCs, EU written confirmations from CDSCO (Central Drugs Standards Control Organization) Application and Renewals for Test license, Trading license, Loan license, Additional products, GMP, WHO GMP, EU GMP, Free sale certificates, CoPP (Certificate of Pharmaceutical Product), CoS (Certificate of Suitability), from State Licensing Authorities (DCA: Drugs Control Administration) by considering respective Acts, regulations and Schedules which ever applicable in force. Import Licenses from DCGI (Drugs Controller General of India) Food License from FSSAI (Food Safety Standards Authority of India) including New Product/ New Ingredient Approvals Intellectual Property Rights Filing application for Trademarks, Name search using online tools, Knowledge on NICE International classification for Goods and services. Filing for Copyright, understanding on Berne convention updates, Basics on Patents, Filing of Preliminary/ Provisional and Complete specifications, Compiling scientific opinions etc Unibiotech Pharma Ltd Mar 2009 Oct 2010 as Sr. Executive Business Development JOB PROFILE: Promoting the Company, Products & Services through various activities and sources. Conducting conferences and CME (Continuous Medical Education) meets, Product presentations, updating feedbacks using RCPA (Retail chemist prescription audits) etc EDUCATION Pursuing PhD from University of Hyderabad under the guidance of Dr. Jagadish PG Diploma in Pharma Regulatory Affairs from Bioinformatics Institute of India, Noida (2011-12) M. Sc (Biochemistry) from Bharathidasan University with 78% (2006-08) B. Sc (Biotechnology, Biochemistry and Chemistry) from Kakatiya University, with 83 %. (2003-06) Intermediate: Bi.P.C (Biology, Physics and Chemistry), with 79 %. (2001-03) SSC: Tagore Vidyaniketan High school with 83% (2001)
PROJECT Cloning and purification of fluorescent protein mtangerine from DH5留 bacteria under the guidance of Dr. Srikanth Chalasani in Indegenese Biotechnologies, Hyderabad between Dec 2007 Mar 2008 TECHNICAL SKILLS Packages: MS Office (Word, Excel, PowerPoint, Publisher), Adobe tools (PDF Creator, Acrobat file editor, extractor and compressor) Languages: C, HTML, XML Operating System: Windows, DOS, Linux Others: Google Sketch up, Logo creator, Tableau Public, Lorenz eCTD docubridge, e Validator, Cunesoft eCTD maker. PERSONAL DETAILS Address : Plot no: 8, CBCID officers colony, Hydernagar, Hyderabad Phone : 8019950842 Email : sathishmutya@outlook.com Web : http://tinyurl.com/satheeshrecv (Info graphic CV) Date of Birth : 18th May 1985 Marital Status : Single Language Known : English, Hindi, Telugu and Tamil Location preference : Hyderabad PAN no : BDVPM5194A For Recruiters information: Current annual CTC: 210000 Expected CTC: 273000+ Notice period: 1 month Note: willing to relocate anywhere in India Flexible for Rotational shifts

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Satheesh Mutya CV

  • 1. SATHEESH KUMAR MUTYA SUMMARY A dynamic professional with 3.9 Years of experience in Regulatory Affairs and 1.7 years of experience in Business Development. Expertise in Literature search, Data presentation, ICH Guidelines, Regulatory submissions, Drug licensing and Acquaintance with Electronic regulatory documentation standards. WORK EXPERIENCE Spansules Formulations Since Nov 2010 as Sr. Executive Regulatory Affairs Regulatory documentation: Preparation and review of Applicant and Restricted parts of DMF (Drug Master Files) / Dossiers for drug registration in ICH, ACTD (Common Technical Document) formats in particular, the documents required for Module 3 and NeeS. Dossiers in accordance with the guidance from various Authorities viz EMA, GCC, SFDA, TGA, WHO etc. Knowledge on Granularity of document annexed by ICH for Organization of CTD. Understanding on e CTD with Module 1 regional XML DTD (Document type definition), XSD (XML schema definition), Study tagging files, md5 checksums header, style sheets and linking in XML. Consistently working with GDP (Good Documentation Practice) and in touch with Annual Reports and Amendments published by DGFT, DCGI and Pharmatimes etc. Review and verification of documents in pursuant to Chemistry, Manufacture and Control (CMC) of drug product in regulatory perspective viz Technical information files, Product development reports (CDSCO draft guidance, ICH Q8) / BCS (Bio Pharma Classification System) classes; Particle or pellet size reports, (Micronization / Statistical interpretations); Pharmacopoeia monographs, comparative analyses and CAPA reports; Analytical methods and validation (USP1225) or verification (USP1226); Labeling aspects; Stability protocols and reports, SUPAC (Scale up post approval changes); Material safety data sheets and Documentation exhibits; Confidential Disclosure Agreements / Indemnification agreements.
  • 2. Licensing Export NOCs, EU written confirmations from CDSCO (Central Drugs Standards Control Organization) Application and Renewals for Test license, Trading license, Loan license, Additional products, GMP, WHO GMP, EU GMP, Free sale certificates, CoPP (Certificate of Pharmaceutical Product), CoS (Certificate of Suitability), from State Licensing Authorities (DCA: Drugs Control Administration) by considering respective Acts, regulations and Schedules which ever applicable in force. Import Licenses from DCGI (Drugs Controller General of India) Food License from FSSAI (Food Safety Standards Authority of India) including New Product/ New Ingredient Approvals Intellectual Property Rights Filing application for Trademarks, Name search using online tools, Knowledge on NICE International classification for Goods and services. Filing for Copyright, understanding on Berne convention updates, Basics on Patents, Filing of Preliminary/ Provisional and Complete specifications, Compiling scientific opinions etc Unibiotech Pharma Ltd Mar 2009 Oct 2010 as Sr. Executive Business Development JOB PROFILE: Promoting the Company, Products & Services through various activities and sources. Conducting conferences and CME (Continuous Medical Education) meets, Product presentations, updating feedbacks using RCPA (Retail chemist prescription audits) etc EDUCATION Pursuing PhD from University of Hyderabad under the guidance of Dr. Jagadish PG Diploma in Pharma Regulatory Affairs from Bioinformatics Institute of India, Noida (2011-12) M. Sc (Biochemistry) from Bharathidasan University with 78% (2006-08) B. Sc (Biotechnology, Biochemistry and Chemistry) from Kakatiya University, with 83 %. (2003-06) Intermediate: Bi.P.C (Biology, Physics and Chemistry), with 79 %. (2001-03) SSC: Tagore Vidyaniketan High school with 83% (2001)
  • 3. PROJECT Cloning and purification of fluorescent protein mtangerine from DH5留 bacteria under the guidance of Dr. Srikanth Chalasani in Indegenese Biotechnologies, Hyderabad between Dec 2007 Mar 2008 TECHNICAL SKILLS Packages: MS Office (Word, Excel, PowerPoint, Publisher), Adobe tools (PDF Creator, Acrobat file editor, extractor and compressor) Languages: C, HTML, XML Operating System: Windows, DOS, Linux Others: Google Sketch up, Logo creator, Tableau Public, Lorenz eCTD docubridge, e Validator, Cunesoft eCTD maker. PERSONAL DETAILS Address : Plot no: 8, CBCID officers colony, Hydernagar, Hyderabad Phone : 8019950842 Email : sathishmutya@outlook.com Web : http://tinyurl.com/satheeshrecv (Info graphic CV) Date of Birth : 18th May 1985 Marital Status : Single Language Known : English, Hindi, Telugu and Tamil Location preference : Hyderabad PAN no : BDVPM5194A For Recruiters information: Current annual CTC: 210000 Expected CTC: 273000+ Notice period: 1 month Note: willing to relocate anywhere in India Flexible for Rotational shifts