Mayank Upadhyay - CV 01-July-2015 Updated.
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This resume summarizes Mayank Shekhar Upadhyay's career experience and qualifications. He has over 2 years of experience working in drug formulation and regulatory affairs roles for Sun Pharmaceutical and MDC Exports. He holds an M.Pharma in Pharmaceutics from Rajiv Academy For Pharmacy and a B.Pharma from IIMT College of Pharmacy. He is a registered pharmacist and life member of IPGA with expertise in preparing and submitting drug dossiers for international markets. His objective is to utilize his skills in a challenging role that provides learning opportunities to help achieve organizational goals.
Mayank Upadhyay - CV 01-July-2015 Updated.
- 1. MAYANK SHEKHAR UPADHYAY Email : upadhyaymayank09@gmail.com; upadhyaymayank69@yahoo.com Male, DOB: July 1st 1985. Mob- +91-9540652631, +91-8126731233 Address: 293-1st Floor, Sector 15 Parts-I, Gurgaon, Haryana. WORK EXPERIENCE : 2 Years 5+ Months CAREER OBJECTIVE: To perform in a challenging atmosphere those provide ample opportunity for learning & utilization of my skills for fulfilment of organizational objectives. Sun Pharmaceutical Industries Ltd. (Ranbaxy Laboratories Ltd.) Executive Drug Formulation Contract Manufacturing (DFCM) & Loan License (Business Development ) Aug14 Present Accountabilities Drug Formulations Contract Manufacturing Client Relationship Management Business Coordination for OTIF MIS / Data Management Business Agreements Project Management/Project tracking and Execution/Deliveries Job Profile Identification and selection of contract manufacturing sites, Project monitoring and coordination with R&D/PDL/RA and partners technical team to complete task as per timeline. Coordinate and bridge the gap between the internal team and partners (CMO) team for timely closure of agreements like Confidentiality Disclosure Agreements, Term Sheet, Definitive Agreements (Manufacturing & Supply/Loan Licensing), Quality Agreements and their amendments. Project monitoring and execution in coordination with CFTs for US, EU, SA, WHO & Emerging market countries. Regulatory submission & Commercial supplies for US, PEPFAR, WHO and EM countries. Ensure the readiness of product artworks during Integration of Ranbaxy & Sun Pharma for the supply continuity Coordinate between hub managers to ensure OTIF (On Time in Full Delivery) as per the agreed timeline for LL, P2P & Contract Manufacturing projects. To raise PO in (SAP system) as per DF-CM head and managers instruction and coordination with Partners and commercial team to meet the NDR. Liaison with Packaging/RA/IP/GM and Partners for finalization of AW/ Integration AW. Budgeting exercise for the FY 2015-16 in coordination with CFTs Interface Internal Business/Legal/Quality /Finance/Material Sourcing/Planning/Supply Chain/ Regulatory/R&D/AD/ PDR. External - Alliance Partners (Senior Management, Project Managers, Business Development, Quality Assurance, Quality Control, Technology Transfer, Purchase, Supply Chain and Regulatory Teams) Achievements Involved in production planning (RM/PM arrangement) of Soft Gelatine Capsules, ARV products and their commercial supply. Smooth transition from Ranbaxy to Sun Pharma is achieved. Involved in filing of finished products in PEPFAR, US, SA, WHO, ASEAN and EM countries & Approvals. Tech transfer of ARV product in SA. MDC Exports Pvt. Ltd. (Export Division of MDC Pharmaceuticals Pvt. Ltd.) Officer Drug Regulatory Affairs Nov13 Aug14 Accountabilities Preparation, review & submission of Dossiers (CTD, ACTD & Country specific format). Renewal of Product Registration. Review of regulatory deficiencies and preparation of response to the queries. Job Profile Preparation, review & submission of Dossiers (CTD, ACTD & Country specific format). To arrange and review the technical documents for registration of Finished Drug Products. Filing of dossiers for Powder for Injections, Tablet/ Capsules, Syrup, Food supplements in CIS, ASEAN, LATAM, FWA &ROA. Finalization of Carton/Label AWs. Interface Internal Quality/Production /Finance/Material Sourcing/Planning/Logistics. External - Alliance Partners, Regulatory Authorities (MOHs), Quality Assurance, Supply Chain & Country RA. Achievements Registrations of Powder for Injections in ASEAN, LATAM and CIS countries. Registration of Tablet & Sustained release Capsule formulations in LATAM countries. Registration of Food supplements in Jordan. Renewal of registration in ASEAN countries. Asmoh Laboratories Ltd. Officer Drug Regulatory Affairs Feb13 Nov13 Accountabilities Preparation and Review of Dossiers (CTD, ACTD & Country specific format) & their submission. Review of regulatory deficiencies and preparation of response to the queries. Arrangement of Documents, Samples and logistics for dispatch of dossiers to Country RA for their submissions.
- 2. Job Profile Filing of dossiers for Tablet/ Capsules formulations in ASEAN, ROA, FWA, Latin American and ROW/ EM. Review & finalisation of artworks / printed material / packaging material. Achievements Registration of Tablet formulations in LATAM, ASEAN & ROA countries. Internships & Projects Dissertation Title: Development and Evaluation of Bioadhesive-Hollow Microspheres of Riboflavin. Guide: Dr.(Prof.) Mrs. Kamla Pathak, HOD (Pharmaceutics) Rajiv Academy for Pharmacy, Mathura (U.P.) Skills Acquired: Fundamental knowledge of handling of instruments such as HPLC, UV, FTIR, Dissolution apparatus & interpretation of data from various novel methods of analysis i.e. UV, HPLC, SEM, DSC, FTIR etc. Internship 45 days Industrial training in Production and Quality Control of Tablet, Capsule & Syrup at Abyss Pharma Pvt. Ltd., Mayapuri Industrial Area, New Delhi. Publications/Seminars/Symposium/Conferences Attended Publication Mayank Shekhar Upadhyay and Kamla Pathak, March (2013), Glyceryl monooleate-coated bioadhesive hollow microspheres of riboflavin for improved gastroretentivity: optimization and pharmacokinetics. Drug Deliv. and Transl. Res.,(doi: 10.1007/s13346-013-0143-1). Conferences 60th Indian Pharmaceutical Congress 2008, (Host: IPGA), New Delhi, India. 25th (Silver Jubilee) IPGA National Conference 2009, 7-8th Nov (IFS College of Pharmacy, Moga), Punjab, India 26th Annual Conference of IPGA, 2nd April 2011, New Delhi, India Seminars Drug regulation in India- current Scenario, 21st Nov 2009, Host: IIMT Gr. Noida Emerging Trends in Pharmaceutical Sector in India (Under the aegis of IPGA), 24th March 2012, Host: Rajiv Academy for Pharmacy, Mathura (U.P.) Rx 2006, Rx 2007, Rx 2008 & Rx 2009 at Jamia Hamdard University, New Delhi Awards & Achievements *Registered Pharmacist *Life time member of IPGA Academic Qualified GPAT 2010 Exam with 90.0 percentile Scholarship from collage (I, II, III & IV year) for good Academic performance. 2nd prize winner in Essay Writing Competition in National level Seminar. Current CTC 3.0 Lac/ Annum Expected CTC Flexible Notice period : 01 Month References: 1. 2. 3. Declaration: I declare that the particulars given in this resume are true to the best of my knowledge and belief. Date: 01 Jul 2015 (Mayank Shekhar Upadhyay) Place: Gurgaon Academic Profile M. Pharma (Pharmaceutics) Rajiv Academy For Pharmacy, Mathura 72.11% B. Pharma IIMT College of Pharmacy, Gr. Noida 76.1% B. Sc. (Bot, Chem) Ewing Christian College, Allahabad 57.9% Class XII M.M.Town Inter College, Ballia 60.6% Class X R.S.H.S.School, Sonwani, Ballia 59.5%