Aparna Mirashi Prabhune
Senior Manager at WOCKHARDT LIMITED
Summary
She has
been in regulatory since 2004, with almost 10 yrs of RA experience.
Working in RA is great as its a challenging job and with a luck to work
with good companies, it has added more feathers to my cap. Hope to
explore regulatory affairs, more than what i have done in the coming
years
Specialties: Regulatory Affairs / Pharmacovigilance
Education
Experience
Senior Manager Regulatory Affairs
Wockhardt
Preparation
of registration Dossiers (Marketing Approvals, Product registrations,
Import Licenses, Clinical Trial Approvals, Test Licenses) for Finished
Formulations (Pharma, Cosmetics) & API
Application of Licenses (Import / NOC) and Approvals of Food Products to FSSAI (Zonal & Central Bodies).
Direct dealing with different parties
Regular follow-up with FDAs on approvals.
Answering queries received from FDAs on the applications made.
Submission of Post approval variations to respective Health Authorities.
Maintenance of Track records all the approval received and applications made to respective Regulatory authorities.
On time Renewal of registrations/ approvals.
Creation / Updation of packaging materials including Package inserts for Local/ Global products.
Review and approval of promotional materials
Preparation of Quality Documents (SOPs)
Active Involvement in planning of Regulatory strategy for new product approvals and launch in countries.
Application of Licenses (Import / NOC) and Approvals of Food Products to FSSAI (Zonal & Central Bodies).
Direct dealing with different parties
Regular follow-up with FDAs on approvals.
Answering queries received from FDAs on the applications made.
Submission of Post approval variations to respective Health Authorities.
Maintenance of Track records all the approval received and applications made to respective Regulatory authorities.
On time Renewal of registrations/ approvals.
Creation / Updation of packaging materials including Package inserts for Local/ Global products.
Review and approval of promotional materials
Preparation of Quality Documents (SOPs)
Active Involvement in planning of Regulatory strategy for new product approvals and launch in countries.
Manager-Head of Regulatory Affairs and Drug Safety
Merck KGaA
Regulatory
Preparation of registration Dossiers (Marketing Approvals, Product registrations, Import Licenses, Clinical Trial Approvals, Test Licenses) for Finished Formulations , API and Devices.
Application of Licenses (Import / NOC) and Approvals of Food Products to FSSAI (Zonal & Central Bodies).
NOC applications to Zonal Office (DCGI) for Exports and Local Manufacturing.
Direct dealing with different parties
Regular follow-up with FDAs on approvals.
Answering queries received from FDAs on the applications made.
Submission of Post approval variations to respective Health Authorities.
Maintenance of Track records all the approval received and applications made to respective Regulatory authorities.
On time Renewal of registrations/ approvals.
Creation / Updation of packaging materials including Package inserts for Local/ Global products.
Review and approval of promotional materials
Preparation of Quality Documents (SOPs)
Active Involvement in planning of Regulatory strategy for new product approvals and launch in countries.
Drug SafetyPreparation of registration Dossiers (Marketing Approvals, Product registrations, Import Licenses, Clinical Trial Approvals, Test Licenses) for Finished Formulations , API and Devices.
Application of Licenses (Import / NOC) and Approvals of Food Products to FSSAI (Zonal & Central Bodies).
NOC applications to Zonal Office (DCGI) for Exports and Local Manufacturing.
Direct dealing with different parties
Regular follow-up with FDAs on approvals.
Answering queries received from FDAs on the applications made.
Submission of Post approval variations to respective Health Authorities.
Maintenance of Track records all the approval received and applications made to respective Regulatory authorities.
On time Renewal of registrations/ approvals.
Creation / Updation of packaging materials including Package inserts for Local/ Global products.
Review and approval of promotional materials
Preparation of Quality Documents (SOPs)
Active Involvement in planning of Regulatory strategy for new product approvals and launch in countries.
Responsible for overall functioning of Drug Safety in India including
Reporting of the Adverse Drug Reactions generated for company products, to DCG (I).
Updation and Maintenance of Pharmacovigilance Master File
Updation and Maintenance of Safety data Exchange Agreements
Updation and Maintenance of Quality Documents
Monthly Literature Screening for SAEs
Daily Website screening for SAEs reported
Review of Clinical Trial Protocols etc
Officer-Regulatory Affairs
Khandelwal Laboratories Pvt Ltd
Involved
Preparation of dossiers for African countries like Mali, Kenya, Burkina
Faso, Senegal, Cameroon, Dominican Republic, Ivory Coast, Ethiopia and
Nigeria. Also for American countries like Jamaica, Haiti & Trinidad
& Tobago, Asian countries like Srilanka, Bhutan and CIS countries
like Kazakhstan, Russia.
Handled tenders for Congo, Cameroon, Zambia and East Caribbean Tender (St.Lucia).
Answered queries for Pharmacy Poisons Board, Kenya.
Handled tenders for Congo, Cameroon, Zambia and East Caribbean Tender (St.Lucia).
Answered queries for Pharmacy Poisons Board, Kenya.
Regulatory Affairs
Cipla
Prepared dossiers for Myanmar, Venezuela, Senegal, Burkina Faso, Ghana, Burundi, and Zimbabwe
Handled tenders for countries like Libya, Benin, Rwanda, Zimbabwe, Ghana, Mali, Sudan, Senegal and Zambia-Canada Tender.
Answered queries for Zimbabwe & Venezuela.
Forwarded Export Orders for Ghana
Handled tenders for countries like Libya, Benin, Rwanda, Zimbabwe, Ghana, Mali, Sudan, Senegal and Zambia-Canada Tender.
Answered queries for Zimbabwe & Venezuela.
Forwarded Export Orders for Ghana
Chemist
Chemo Test Labs
Analysis of Raw Materials and Finished formulations
Volunteer Experience & Causes
Opportunities Aparna is looking for:
- Joining a nonprofit board
Causes Aparna cares about:
- Children
- Environment
- Human Rights
- Disaster and Humanitarian Relief
- Social Services
Organizations Aparna supports:
.
Padmashree Dr D. Y. Patil Vidyapeeth
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