regulatory affairs Resumes in South Africa-Gauteng-Johannesburg: shitalkumar

regulatory affairs Resume

Contact Candidate

Name:

shitalkumar

Location:

South Africa-Gauteng-Johannesburg

Experience:

Willing to Relocate:

Willing to Travel:

Most Recent Job Title:

regulatory affairs

Personal Website:

Objective:

working for the non regulated market recently eager to graspe apportunity to work at south africa

Resume Text:

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English, Hindi, Marathi.
Hobbies : Reading, Traveling, Music.
Passport Number : F8857632

Work experience:

• Working in Sirmaxo Chemicals Pvt Ltd as Executive in Regulatory Affairs since April 2006.

• Worked in Elder Pharmaceuticals Ltd from Jan. 2005 to Apr.2006 as Officer in Regulatory Affairs.

• Worked in Samrudh Pharmaceutical Pvt Ltd as Trainee Production Chemist from Sep. 2004 to Jan. 2005.

• Appeared for Industrial Training at Magnachem Pharmaceuticals Pvt Ltd.

Job Responsibilities:

• Collecting data, samples, and documents and preparing necessary documents to support the product approval process for specified international markets.
• Understanding the regulatory requirements and developing strategies to ensure that the requirements and the company objectives are met.

• Co-ordinating with R&D, Q.A., Production and Medical Department for collection of Technical and Medical data for compilation of Registrations Dossiers.

• Handling queries of different regulatory bodies.

• Executing export orders.

• Recommending alternative strategies to deal with the changes in the regulatory requirements to achieve the planned objectives.

• Updating & complying with new regulatory guidelines.

• Internet & literature referencing for clinical and toxicity data for the different active pharmaceutical ingredients.

• Preparation of dossiers for Asian, African and Latin American countries.
• Responsible for procurement of FDA documents, scrutinization of the same.
• Responsible for arranging required documents for application of new product COPPs, Product licences and other FDA documents.
• Responsible for development of Artworks for different countries.
• Responsible for submission of Technical Tender Documents for International markets.
• Responsible for procurement of all technical data from factory and scrutinization of the same, maintenance of the master files for all products.
• Currently countries look after are Myanmar, Trinidad & Tobago, Ethiopia, Malawi, Chad, Kenya, Mozambique etc.
• Countries successfully handled are Oman, Kuwait, Srilanka, Georgia, Uganda, Solomon Islands, Sudan, etc.
• Also having registration experience with Private procurement agencies like Mission Pharma, Imres, IDA, Unisef, WHO & MSF.

Educational Qualifications:

Appearing for M.B.A. correspondence from Sikkim Manipal University. ( Two semesters completes with first class.)

Appearing for the industrial programme in Pharma Regulatory Affairs offering by Institute of Bioinformatics Noida (U.P.)

B.Pharm. (First class, 2003-04)S.V.P.M’s College of Pharmacy, Baramati - Pune university

D.Pharm . (First class, 2000-01) Institute of pharmacy, Miraj. - MSBTE

Computer Proficiency:

• Windows based programs such as Office XP( Ms world, PowerPoint, Excel)

Attended Seminars:

• Revised schedule M.
• Documentation in Pharmaceutical industry.
• ISO- Awareness programme.

Place: Mumbai Yours Truly,

Date: (Shitaklkumar Takale)

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