Regulatory affairs-officer Resume
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Resume:
From Onwards I am working with Astra lifecare (India) Pvt. Ltd, ahmedabad from last months
Preparation and review of the dossiers as per the current prescribed guidelines of the respective regulatory authorities. | |
Collection of various pharmacological, pre-clinical & toxicological data. | |
Review of the quality and analytical data as per the pharmacopoeia, specification, MOA, STP, batch records, Stability, Finished product / Packaging material data for the purpose of compilation of the dossier. | |
Co-ordinating in sample management and submission to the regulatory authorities. | |
Maintenance of the office copies of the sent dossiers / documents/samples. | |
Perform additional regulatory related duties as and when required, assigned by the IRA team leader. | |
Preparation / Review of labelling & packaging material, Packing inserts the finish formulation marketing materials, promotion materials under supervision. | |
Provide regulatory support / inputs to various departments as and when required. | |
Preparation of dossiers for Medical devices. |
r M. Pharm. Part II (Pharmaceutical chemistry) from ABMRCP Bangalore, RGUHS, Bangalore: .% (Distinction)
r M.Pharm. Part I (Pharmaceutical Chemistry) from ABMRCP Bangalore, RGUHS, Bangalore in : .% (Distinction)
r B. Pharm. from RGUHS,Mangalore in: .% (Distinction)
r HSC form A-One High school,Ahmedabad in : %
r SSC from A-One High school,Ahmedabad in : .% (Distinction)
r Taken pharma training for months under Karnataka pharmaceutical trust, Bangalore for months during M.pharm which involved Intellectual property right (IPR), Dossier preparation for registration of drug, ICH guidelines(Q, Q, Q),Pharmaceutical manufacturing processes(solid, parentrals, liquid orals), Pharmaceutical testing & specifications, Validation, Calibration, CAPA, Deviation, Analytical method development stability guidelines, Clinical trials, Pharmaceutical packaging,.
r Attended seminar on Quality management system and Quality risk management given by Mr S.M. Mudda executive vice president from Micro labs.
r Synthesis of compounds
r Prediction of ultraviolet, IR, NMR and Mass Spectroscopic data
r Designing of molecules by QSAR & Molecular Docking studies.
r Follow through with a plan or decision.
r Indentify problems and needs.
r UV (Shimadzu)-
r FT-IR (Bruker) Tensor-
r Dissolution apparatus
r Disintegration apparatus
r Microwave Oven
r Molegro virtual docker
r Hyperchem,
r ACD Chem Sketch, ChemDraw, ISIS Draw
Research Topic: “Synthesis, chereterization and pharmacological activity of few substituted pyridine derivatives.”
r Abstract: ,-Dihydropyridine and its heterocyclic derivatives have shown diverse chemical reactivity and broad spectrum pharmacological activity. They are reported to possess important therapeutic properties such as antagonist of a platelet activating factor, novel nonpeptidic HIV- protease inhibitor, antimicrobial, bronchodilatory, anticonvulsant etc.
r Synthesis: Preparation of ,-dihydro Pyridine was prepared by Microwave Tecnique in which undergoes mannich reaction with sulphanilamide, reaction mixture was reacted with Schiff base to give different aldehyde derivatives which was cyclised by mercapto acetic acid to give different thiazolines.
r Pharmacological Activity: synthesized novel derivatives were screened for analgesic activity in Swiss mice, anti-inflammatory activity in Wistar rats, in vitro antibacterial and antifungal activity and antitubercular activity. Some compounds found to be moderate pharmacological activity. And some shows comparable activity with standard.
r Cadila Pharmaceuticals Ltd, Ahmadabad
r Micro labs(Parentral Unit), Bangalore
r Kamwell pharmaceuticals, Bangalore
r R M fine chemicals, Bangalore
r Attended th Indian Pharmaceutical Congress- held at Ahemdabad.
r Attended nd Annual Convection of Association of Biotechnology and Pharmacy & National Seminar on “Pharmacogenomics and its Application in Drug Discovery,” - Jan. at Acharya & B. M. Reddy College of Pharmacy, Bangalore Attended nd IPA Students` Congress, organized by Acharya & B. M. Reddy College of Pharmacy, Bangalore
r Attended th Indian Pharmaceutical Congress- held at Delhi.
r Attended seminar on “green chemistry” held at Mysore.
r Poster presented on “Recent approches in combinatorial chemistry in nd Annual Convection of Association of Biotechnology and Pharmacy at Bangalore.
r Poster presented on “Synthesis and antimicrobial activity of ,-dihydropyridine derivatives” in nd IPA Students` Congress seminar held by IPA at Bangalore.
r Poster presented on “Recent approches in Green chemistry” in IPA seminar at Mysore.
r A registered member of Karnataka State Pharmacy Council.
r A registered member of Indian Pharmaceutical Association (IPA)
Selected as an IR in charge to operate IR Spectrometer in College
r Academic Award:
ü nd rank in Poster presentation on on “Recent approches in combinatorial chemistry at nd Annual Convection of Association of Biotechnology and Pharmacy & National Seminar on Pharmacogenomics and its Application in Drug Discovery; - Jan. at Bangalore.
- Regulatory affairs
- Quality assurance
- Date of Birth th April
- Father’s name Patel Jayeshkumar P
- Gender Female
- Marital Status Single
- Languages English, Hindi & Gujrati.
- Nationality Indian
I hereby declare that the above-mentioned information is correct to the best of my knowledge and belief.
Patel Ruchi Jayeshkumar
