Curriculum Vitae:
Manish Naithani
Mail Id- : naithani34 AT gmail.com
Carrier Summary :
Obtain a challenging leadership position, applying creative problem solving and lean management skills with a growing company to achieve optimum utilization of its resources and maximum profits.
Current Working:
Themis Medicare Limited , Haridwar from Dec. 2009 to till date (Regulatory Affairs, Sr. Officer)
Jobs & Responsibilities- :
** Responsible for preparing, submitting applications for Manufacturing License, Loan License, COPP, FSC to State FDAs & Central FDAs, required for registration purpose. Handling of Applications [Registration, Marketing Approvals, Import Licenses, Test Licenses, Clinical Trial NOC and Report Submissions] for finished formulations (Pharmaceuticals Products) in India.
** Regulatory activities [Registration, Marketing Approvals, Import Licences, Test Licenses, Clinical Trial NOC and Report Submissions - Fillings, follow-up and product life cycle management] for finished formulations (Pharmaceuticals) Domestic, ROW & CRO pdts.
** Responsible for preparing, submitting applications for CDSCO.
** Responsible for preparing, submitting applications for cGMP, GMP & GLP.
** Responsible for preparing, submitting applications for Tender as M M C, Performance Certificate, Non-Connivance etc.
** Responsible for preparation, submission & compliance of countries specifics CTD & ACTD Dossiers.
** Responsible for Registration of Drug Products in MCC, GCC, EMEA-MHRA & CRO Stakeholders.
** Handling Computer Hardware & Networking issues. Knowledge of Photoshop, ERP, Oasis Lims, Typing (English & Hindi).
** Sound knowledge of IT Infrastructure.
Previous Experience:
Akums Drugs & Pharmaceuticals Ltd.
Haridwar (Apr.2009 to Nov.2009) (Regulatory Affairs Officer)
Jobs & Responsibilities- :
** Responsible for preparation, submission & compliance of countries specifics CTD & ACTD Dossiers.
** Responsible for Registration of Drug Products in MCC, GCC, EMEA-MHRA & CRO Stakeholders.
** Responsible for preparing, submitting applications for Manufacturing License, Product License, Loan License, COPP, FSC to LFDA & Central FDA .Experience in making applications for New products& Dossiers
Technical Qualification- :
** Basic Knowledge of Computer (MS Office) with CCC Certificate DOEACC Society.
** English/Hindi Typing & Working knowledge of ERP.
** Something Knowledge of networking/hardware with DCHN (Lalbhadhur Sastri Training Insituate).
Academic Qualification:
** High School (Science Group) in UP Board
** Intermediate (PCM Group) in UP Board
** Graduation (Arts & PCM Group)
** Post Graduation [Eco. & MBA (HR)].
Personal Details:
Father’s Name : Sh. K.P. Naithani.
Mother’s Name : Smt. Subhodhani Naithani.
Date of Birth : 01.08.1978
Marital Status : Married
Nationality : Indian
Strength:
** Able to work in challenging/pressure situation. & honestly & diligent.
** Ability to working with Team.
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