DR ANTHONY MELVIN CRASTO,WorldDrugTracker, helping millions, A 90 % paralysed man in action for you, I am suffering from transverse mylitis and bound to a wheel chair,With death on the horizon, This will not stop me, Gods call only..........
DR ANTHONY MELVIN CRASTO Ph.D ( ICT, Mumbai) , INDIA 29Yrs Exp. in the feld of Organic Chemistry,Working for GLENMARK PHARMA at Navi Mumbai, INDIA. Serving chemists around the world. Helping them with websites on Chemistry.Million hits on google, world acclamation from industry, academia, drug authorities for websites, blogs and educational contributio
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Wednesday 7 October 2015

Aparna Mirashi cares for children, social work

Aparna Mirashi

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





Pune

MBA; Diploma, Marketing (International Business)
2000 – 2004
Distance): Completed Post



Aparna Mirashi

 

 

 

Experience





Senior Manager Regulatory Affairs

Wockhardt
August 2013 – Present (2 years plus), Mumbai Area, India
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.




Manager-Head of Regulatory Affairs and Drug Safety

Merck KGaA
April 2008 – July 2013 (5 years 4 months)Mumbai Area, India
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 Safety
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
May 2006 – April 2008 (2 years)
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.





Regulatory Affairs

Cipla
November 2004 – April 2006 (1 year 6 months)
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





Chemist

Chemo Test Labs
June 2004 – November 2004 (6 months)Mumbai
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:

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Padmashree Dr D. Y. Patil Vidyapeeth

 Map of D.Y. Patil University

 

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