Ankita Hingu
Regulatory Affairs Associate at Naxpar Pharma Pvt Ltd - India
- Role
- Regulatory Affairs Associate at Naxpar Group
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Ankita Hingu
Dossiers filings for Prescription Medicines, Over the Counter drugs (OTC), Herbal Preparations, Dietary/Food supplements, Nutraceuticals in International markets as per business plan. Accountable for the timely preparation and filing of submissions, follow-up and approval of new Marketing Authorizations in line with agreed business plans. To ensure all regulatory submissions, correspondence and approvals are accurately communicated, recorded. Approval of product labeling (Artworks) & Promotional Material. Review of high quality CMC documentation during product registration and templates, respecting CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed timelines for Pharmaceutical products & Consumer products (OTC). Dossier Collation – Reformatting information into CTD/ACTD/Dossier format as per country specific requirement for submission to the Regulatory Agencies of the various countries. Coordinating with manufacturing sites & legal department for obtaining Ancillary documents. Variations to existing products, renewals.
Experience
Regulatory Affairs Associate
Dec 2018 — Present · Mumbai, IN
Dossier Collation – Reformatting information into CTD/ACTD/Dossier format as per country specific requirement for submission to the Regulatory Agencies of the various countries. Reviewing the dossiers prepared by team members before submitting to Authorities / Registration managers and taking the complete responsibility of error free dossiers. Provide support to Global regulatory team for every product.
Education
MET - Mumbai Educational Trust's Institute of Pharmacy
Diploma Pharmacy
2003 — 2005
Dr. Bhanuben Nanavati College of Pharmacy
Bachelor of Pharmacy
2005 — 2008
Sikkim Manipal University of Health, Medical and Technological Sciences
Master of Science (MSc), Clinical Research and Regulatory Affairs
2012 — 2014
Haffkine Institute , Mumbai
PG Diploma, Clinical Research & Regulatory Affairs
2011 — 2012
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