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Regulatory Affairs Officer/Executive, Regulatory affairs, - Job Wanted - BioTech / Pharma

Resume ID:9664
25-07-2011

Sunita pavankumar Patil, BPharm, 1-2years of Exp.
Job Wanted in Other Officers Resumes

Name:	Sunita pavankumar Patil
Age:	25
City / Town:	Mumbai
Qualification:	BPharm
Subject:	Regulatory affairs
University / Board:	Shivaji University Kolhapur
Grade:	First Class,61.0%

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Job Wanted In Category:

Other Officers Resumes

Training / Expertise:

Industrial trainee, ratiopharm India Private Limited Verna, Goa -403722. One month industrial training taken in following dept: Quality Assurance, Analytical Development, Formulation Development and Scale Up and Quality & stability Control

Experience :

1-2years of Exp.

Current Designation:

Officer regulatory affairs

Type of Current Work:

Compiling & documentation of wide range of datas and information of Regulatory affairs.
Knowledge of regulatory guidelines of various semi regulatory countries.
Information of regulatory strategy, regulatory intelligence and regulatory compliance .Knowledge of various ICH guidelines and cGMP guidelines.
Preparation of registration dossiers for semi regulatory countries according to their official guidelines like Ukraine, Kazakistan , Philippines , Thailand , Shrilanka , Bhutan , Ethiopia, Ghana and Uganda. Latin American countries: Bolivia, Columbia, Peru, Mexico, Guyana and Honduras
Furnishing the scientific responses to deficiency queries received from various regulatory bodies.
Application of Manufacturing Licenses for new products and COPP.
Carrying out the review of BPRs, Deficiency Queries & Response, BPR, PDR, Process Evaluation Data, etc.
Carrying out the review of validation & exhibit reports, stability data, dissolution data, specifications, incidents, patents, etc.
Have acquaintance with CTD filling to various regulatory bodies.
Co – ordination with QA, QC and Production departments for getting samples and documents.
Co – ordination with QA, procurement department and vendors to get approved artwork and printed packaging material for registration.

Work Experience Description:

- Mar 2010 - Till date, Unibios Labratories Ltd., Saki Vihar Road as Officer in Pharma Regulatory Affairs department.
- Nov 2009 – June 2010,Cipla Ltd, Vikhroli as Officer in Pharma Regulatory Affairs department.
- Mar 2009 – Nov 2009, M/S Kilitch Drug India Pvt. Ltd. Navi Mumbai as Officer in Pharma Regulatory Affairs department.
- June 2007, Industrial trainee, ratiopharm India Private Limited Verna, Goa -403722. One month industrial training taken in following dept: Quality Assuran

Achievements:

- Seminar presentation on Mass Spectrometry during I st semester as part of curriculum of

PG-DIAC.

- Project on Green Chemistry submitted to Ramnarain Ruia College, Mumbai as part of curriculum of PG-DIAC.

Job Wanted Title:

Regulatory Affairs Officer/Executive

Expected Monthly Salary RangeRs:

16000 - 25000

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