P - Pharmacist - Chennai, TN, India

Niranjini P

Chennai, TN, India




Preparation of dossiers as per ACTD/CTD and countries specific guidelines,preparation of tender documents & samples.Endorsement/COPP/FSC & NOC

Work History

Senior Executive

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

Executive RAD

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:
Asian Countries
• Bhutan, Cambodia, Hong Kong, Myanmar, Maldives, Nepal, Philippines, Srilanka, Thailand & Vietnam, Yemen.
African Countries:
• 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.
CIS Countries:
• Georgia, Kazakhstan, Kyrgyzstan, Tajikistan, Ukraine & Uzbekistan.
Latin American Countries:
• Bolivia, Chile, Dominican Republic, Guatemala, Guyana, Haiti, Jamaica, Peru, Panama & Trinidad & Tobago.


➢ Regulatory Affairs Department
➢ Documentation.

➢ 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

Skillpages has been acquired by Bark.com!

Bark.com is pioneering the way people find local services. Skillpages is the world’s premier directory of service providers.

Find out more

Are you sure that you want to leave?