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  1. 1. Mobile no: 7406593090 Email: k.venkatachalapathi CAREER OBJECTIVE Looking for a challenging and rewarding career in Pharma regulatory affairs to utilize my skills and abilities to be a part of organization that offers an opportunity for continuous learning, professional growth and good working environment. CAREER SUMMARY  Currently working as senior executive-RA in Regulatory affairs department at Norwich Clinical services.  Worked as Bio-analyst executive in Bio-analytical department at Norwich Clinical Services.  At B.Pharm level underwent Industrial training for 21 days at Madhur Pharma & Research Laboratories (P) ltd- Bangalore.  Qualified GATE-2009 examination with percentile score of 89.66.  Did a certificate course in Bio-analytical techniques at Lotus clinical research academy, Bangalore.  Have knowledge on using UV spectrum, IR instruments, LC-MS/MS and interpretation. WORK EXPERIENCE POSITION : Senior executive-Regulatory Affairs at Norwich Clinical services DURATION: 01-Jan-2014 to till date SUMMARY ABOUT WORK: • Providing Regulatory updates related to clinical research and Bio availability – Bio equivalence from different Regulatory authorities such as CDSCO, US-FDA, EMEA, WHO, ANVISA etc. • Performing impact analysis of gazette notifications, notice orders, minutes of meeting of Apex committee and others, related to clinical research published in CDSCO website on monthly basis. • Coordinating with Project management group for providing Regulatory feasibilities & timelines of projects to be taken for BA/BE studies and clinical trials. Page 1 of 4
  2. 2. • Preparing Regulatory dossiers for applying BE-NOC/IL & Import license as per checklist provided for BA/BE studies and clinical trial studies and their submission to DCGI. • Applying licenses for Export & Import of Biological samples for Bio analysis purpose. • Performing QC for the documents provided by sponsor for a BA/BE application and Clinical trial application and providing inputs if changes or additional information required any. • Performing literature survey for the molecules required for BE-NOC/IL and Clinical trial application. • Coordinating with Ethics committee for approvals and getting acknowledgement for amendments. • Serious adverse event reporting to Regulatory authority within the reporting timelines, and providing responses to the queries issued by regulatory authority. Keeping a tracker for serious adverse events occurred and updating the status of each serious adverse event to relevant departments. • Clinical trial registration in CTRI website, responding to the queries raised by CTRI and timely update of on-going or completed trial in CTRI website. • Bookmarking and linking of the chromatograms & Case report forms of different projects for reporting purpose. • Preparing & submitting the documents required for facility approval & facility renewal to regulatory authorities such as CDSCO, ANVISA, & GDUFA registration for BA/BE center. • Preparation of SOPs for Regulatory department. PREVIOUS WORK EXPERIENCE POSITION : Executive – Bio-analytical Analyst DURATION: 2 years (21-May-2010 to 11-Aug-2011 & 05-Apr-2013 to 31-Dec-2013) SUMMARY ABOUT WORK:  Method Development and Validation of different Molecules using LC-MS/MS in compliance with the Regulatory guidelines & In house SOPs for Bio-analysis.  Have knowledge on using UV spectrum, IR instruments, LC-MS/MS and interpretation Page 2 of 4
  3. 3.  Clinical sample analysis.  Literature search for projects to be undertaken.  Preparation of SOPs and Protocols for projects and other project related documents.  Handling of clinical trial samples. ACADEMIC DETAILS ADDITIONAL QUALIFICATIONS Certificate course in Bio-analytical techniques: Lotus clinical research academy, Bangalore. PROJECTS UNDERTAKEN • Determination and quantification of Bisoprolol in human plasma by LC-MS/MS.  Chromatographic method and extraction of Bisoprolol from human plasma was developed  The method was validated by doing 3 Precision and Accuracy batches. • Synthesis and Evaluation of Novel pyrimido-diazepine derivative.  Derivatives containing pyrimidine and diazepine ring system was synthesized.  Anti-microbial activity screening was performed for synthesized derivatives. Page 3 of 4 EDUCATION UNIVERSITY INSTITUTION YEAR PERCENTAGE M.Pharm Pharmaceutical Chemistry Rajiv Gandhi University of Health Sciences, Bangalore. M.S. Ramaiah College of Pharmacy, Bangalore, Karnataka. 2011-2013 73.14% B.Pharm Rajiv Gandhi University of Health Sciences, Bangalore. M.S. Ramaiah College of Pharmacy, Bangalore, Karnataka. 2009 65.76% Intermediate (10+2) A.P Board Sri chaitanya jr college Hyderabad. 2005 82.30% S.S.C Maharashtra State Board Modern high School Vashi, Navi mumbai. 2003 58.00%
  4. 4. PERSONAL DETAILS Name : K.venkatachalapathi Sex : Male Nationality : Indian Marital Status : Married Languages known : Kannada, English, Telugu, Hindi, Tamil. Computer Proficiency : Internet skills and Basics Hobbies : Photography and exploring new places. . I declare that the information given above is true to the best of my knowledge Date: Place: Bangalore K.venkatachalapathi. Page 4 of 4