Preparation of dossiers as per ACTD/CTD and countries specific guidelines,preparation of tender documents & samples.Endorsement/COPP/FSC & NOC
Regulatory Affairs Department in Axon Drugs Private Limited
From November 2012
Preparation of dossiers as per ACTD/CTD & Countries specific guidelines,Review of BMR,BPR,Validation documents,Endorsement/COPP/NOC,FSC
Regulatory Affairs Department in Medopharm Private Limited
October 2008 - October 2012
➢ Capable to approach the clients with good communication regarding the Registration documents.
➢ Kind attention at team leaders and colleagues regarding the dossiers and questionnaires.
➢ Involves Knowledge in giving notice to applicant for dossier writing.
➢ List of countries handled:
• Bhutan, Cambodia, Hong Kong, Myanmar, Maldives, Nepal, Philippines, Srilanka, Thailand & Vietnam, Yemen.
• Angola, Algeria, Benin, Burkinafaso, Botswana, Bosnia, Cameroon, Chad, Gambia, Congo, Ethiopia, Ghana, Guinea, Kenya, Madagascar, Malawi, Mali, Mauritania, Mozambique, Niger, Nigeria, Rwanda, Senegal, South Africa, Sierra Leone, Togo, Tanzania, Uganda, Zambia & Zimbabwe.
• Georgia, Kazakhstan, Kyrgyzstan, Tajikistan, Ukraine & Uzbekistan.
Latin American Countries:
• Bolivia, Chile, Dominican Republic, Guatemala, Guyana, Haiti, Jamaica, Peru, Panama & Trinidad & Tobago.
AREA OF INTEREST
➢ Regulatory Affairs Department
REGULATORY AFFAIRS - CORE RESPONSIBILITIES
➢ Preparation and Submission of dossiers for registration and re-registration in various countries, [Asian, American, African, CIS countries etc] as per their guidelines [ICH, ACTD & CTD].
➢ Compiling and reviewing the Registration dossier for submission in countries of non -regulated markets.
➢ Collecting data's from Production department relating to the manufacturing of the drug (i.e., Manufacturing formula, Manufacturing Process, Validation of Manufacturing Process etc)
➢ Review of specifications like Raw material, finished product specification and Test Procedures, Validation protocol and stability data, Packing Artworks with reference to country specific requirements for regulatory compliance.
➢ Collecting data's relating to the Clinical information of the drug (i.e., Pharmacology, Pharmacokinetics, Pharmacodynamics, Indications, contra -indications, Adverse effect, Drug Interactions, Dosage &...
Qualifications & Certifications
J.S.S College of Pharmacy
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