Application - Senior Executive Regulatory Affairs

RAHUL THORAT

***,** **/*,******-*,Koparkhairane,Navi Mumbai 400 709. (IND)

Cell : +919*********/+919*********.

************@*****.***,***********@***.**

Key Skills : Regulatory Affairs, Technical services.

Providing Regulatory support to the company in order to obtain Marketing Authorisations for commercial products as rapidly as possible and to maintain these authorizations and provide input into all stages of development and develop strategies to ensure a complete and rapid development. Currently pursuing Industry Program in Pharma Regulatory Affairs of Bioinformatics Institute of India with simultaneously doing MBA in Health Care (SMU).

Strong regulatory background includes knowledge of international registration guidelines and, regulations .Provide regulatory support and assistance in line with the Registration Program in order to ensure the company maintains compliance whilst at the same time meets its business objectives.

Professional Experience:

1) PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS & PHARMACEUTICALS PRIVATE LIMITED)

503 – 504 Ambience Court, Plot 2; Sector 19 D Vashi Navi Mumbai (India). 400703.

http://www.psachem.com/

06 Apr. 2010 TO PRESENT

Senior Executive – Regulatory Affairs

• To achieve the Budgeted and Targeted Regulatory dossiers filings for various Drugs in different countries as per Business plan and periodic updations as per business requirement to launch and expand products in the targeted location/ market

• To write, support and manage projects to prepare high quality medical and scientific communications including patient narratives, literature review, abstracts, slide sets for presentation or for submission to regulatory authorities.

• Leads the development, preparation and maintenance of all marketing applications, registrations (Including CTD,ACTD,Dossiers and Technical files)

• Preparation of the above referenced documents meeting set quality standards and on time for submission to Health Authorities as appropriate. (i.e. complying with standards).

• Ensure full regulatory compliance with all local and international regulations, codes and standards.

• Develop and implement registration strategies and maintain the registration of marketed products

• Ensure compliance of operations with governing regulatory requirements.

• Manage day-to-day operations and delivery for specific regulatory affairs engagements; oversee assigned project, including all aspects of regulatory submissions - compilation & review, responding to queries from regulators.

• Perform additional duties as assigned by Regulatory Affairs Manager & Director.

• Collaborates with other members of the Regulatory Affairs department to coordinate requirements for international regulatory submissions.

• Draft data for SPC, Process Validation, Analytical Validation, Photo stability, and Stability Studies report, Dissolution profile, Certificate of analysis, TAD, STP’s and related Documentation with reports.

• Maintains current knowledge of international regulations and standards affecting company’s products.

• Clinical safety data management - Preparation of PSUR, CCDS, CCSI.

2) MJ - BIOPHARM PRIVATE LIMITED, NARIMAN POINT, MUMBAI 400 021(L-7, TALOJA, NAVI MUMBAI.) http://www.mjbiopharm.com/

05 Dec. 2009 to 02 Apr.2010

Department – Regulatory affairs & Technical services

Regulatory Affairs Officer

• Preparation of registration dossiers, Literature Survey, Finished Product Specification and Standard Test Procedure (STP) for semi regulated and regulated markets.

• Preparation, Review, Submission of Technical and other Documents/Dossiers with Drug Controller General of India/CDSCO/State FDAs for-

- Registration for pharmaceuticals Formulations, New Drug Application).

- Import Licenses, Export Licenses, and Manufacturing & Marketing licenses,-WHO-

- GMP Certification, COPP’s, Free Sale Certificates, and Performance Certificates. Liasioning with DCGI/CDSCO/state FDA offices.

• Regulatory /compliance /third party electronic documentation work upon instruction of VP regulatory & technical services, Manager.

• To ensure that all the relevant dossiers & technical agreements received from respective contract givers are archived properly for reference.

• To archive all master documents under document control security at defined locations.

• Maintenance of the Regulatory archive (paper and electronic systems) by properly storing and retrieving documents in a timely manner according to processes and procedures.

• Sample Management for Registration and for clinical trials.

• Response to the Queries raised by MOH.

• Interact with various departments/ teams to collect documents required for regulatory compilation on time as per regulatory norm.

• Performing additional tasks or special projects as assigned by the Vice President Regulatory Affairs & Technical Services /QA General/Manager from time to time upon requirements.

3) SANJIVANI PARANTAREL LIMITED ,NAVI -MUMBAI-400701

http://www.sanjivani.co.in/

18/02/08 -30/11/2009

Regulatory Affairs Officer

• Liaise with local regulatory authority as well as overseas partners pertaining to regulatory affairs, including medical product registrations, variations to existing products, renewals.

• Preparation, Review, Submission of Technical and other Documents with State FDA.

• Evaluation, compilation & preparation of registration dossiers, preparing registration applications, reporting.

• Preparation of export shipment documentation.

• Response to the queries of regulatory authorities.

• Identify and interpret regulations and guidelines produced by competent authorities.

• Preparation of clear, accessible product labels and patient information leaflets & artworks.

• Preparation of Validation Master plans, validation protocols,.

• Expertise on semi regulated registration submissions.

4) VENKY’ S INDIA LIMITED, PUNE

http://www.venkys.com/

02/05/07-04/02/08

Microbiologist (R &D)

• Production of veterinary vaccines.

• Isolation, propagation, identification of avian viruses.

• Purification of viruses.

• Heamaglutinnation test (HA)/Heamaglutinnation Inhibition test (HI).

• Maintenance of viral cultures by lyophilization.

• Production of antisera against viruses

4) KUTWAL FOODS PVT.LTD, PUNE

http://www.kutwalfoods.co.in/

07/03/2006 - 18/03/2007

Microbiologist HOD

• Responsible for setting up requisite laboratory.

• Physicochemical analysis. Estimation of water hardness.

• Preparation of various media.

• Isolation and identification of Different Families of bacteria.

• Enterobacteriaceae,Coliforms, E.coli, Pseudomonas, Sulphite reducing anaerobes, Yeast, Molds, Salmonella, Shigella, Feacal streptococci, Feacal staphylococci, Vibrio cholera, Vibrio parahemolyticus.

• Responsible for handling visits of BIS, FDA.

5) NOBLE HOSPITAL, PUNE

http://www.noblehospitalspune.com/

02/02/2005 -15/02/2006

Microbiologist

• Working in Microbiology, Hematology, and Serology, Clinical pathology Departments.

Professional Qualification:

IPRA (Industry Program in Pharma Regulatory Affairs)-Bioinformatics Institute of India : Pursuing

M.B.A (HEALTH CARE) – Sikkim Manipal University : Pursuing (II Yr.)

Education:

B.S.C. Examination (Microbiology)-Pune University : Pass

Higher Secondary School Certificate H.S.C. (SCIENCE) : First Class.

Secondary School Certificate (S.S.C.) : Higher Second Class

Software Skills:

• Excellent computer skills - Microsoft applications.

• Windows 7 , Linux

• MS Office 2007

• Adobe/Acrobat/Distiller

• Photoshop CS2

• Corel draw 12.

• Installation of software’s and hardware.

• Diagnostics and Troubleshooting.

• Proficient in .net skills.

• ERP ITM.

Personal Information:

Passport No. : H 7062365

Date of Birth : - 11/07/1981.

Gender : - Male

Marital Status : - Married

Nationality : - Indian

Languages known : - English- Hindi- Marathi.

Notice Period : - 1 Month

Place : - Mumbai.

Rahul Thorat.

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