Kanupriya Budhiraja
Sr. Manager - DRA at Synokem Pharmaceuticals Ltd
links
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- https://in.linkedin.com/in/kbudhiraja
https://www.facebook.com/kanubudhiraja
https://twitter.com/kanubudhiraja
https://plus.google.com/114108592663419658404/about -
Summary
• A seasoned pharmaceutical consultant having around 10 years of progressive experience with many reputed Pharma & Healthcare companies
• A qualified Regulatory Affairs Professional possessing a Post Graduate Diploma in Drug Regulatory Affairs and Gold Medallist in Post Graduation
• Expertise in Regulatory submissions for Regulated, Semi-regulated & ROW markets
• Well versed and updated with CTD, ACTD, ICH, GMP& other Guidelines
• Experience with wide range of Pharmaceutical and Ayurvedic products in various dosage forms – tablets, capsules, syrups, suspensions, dry powders, creams and ointments, Ophthalmic and Otic drops, etc.
Experience
Freelance Regulatory Consultant
Reguserv Consulting
- Providing end-to-end technical solutions regarding various aspects of pharmaceutical products – from its inception till launch.
- Preparation of registration dossiers for submission in Ministry of Health for the purpose of overseas registration & exports
- Preparation of Applications for submissions in CDSCO & DCGI Offices for registration & approvals in India
- Liasoning with Drug Offices
- Preparation of Drug Master Files for APIs
- Regulatory Query handling
- Assistance for developments of technical documents & business strategies
- Providing assistance in conducting Clinical trials/ BA-BE studies
Manager - Regulatory Affairs
Gracure Pharmaceuticals Ltd.
- Registration of pharmaceutical products in various countries across the globe - Kenya, Botswana, Myanmar, Madagascar, Ukraine, Cambodia, etc.
- Guiding team members for development of CTD registration dossiers
- Review of Artwork for pharmaceutical products for various countries
- Coordination with QA/ QC departments
- Troubleshooting in Regulatory Affairs
Assistant Manager - Regulatory Affairs
Ozone Group
- Preparing Regulatory Dossiers & other Export documents for
ayurvedic & pharmaceutical products
- Preparing Detailed Project Reports (DPR) for future
expansion of Ozone Group
- Review of Quality Documents
- Review of Domestic & Exports artworks
- Liasoning with govt. bodies like NPPA, MoEF, etc.
Sr. Executive - Regulatory Affairs
Sentiss Pharma Pvt. Ltd. (Formerly Promed Exports Pvt Ltd)
Preparation of dossiers for registration of pharmaceutical products in Russia & CIS countries on CTD Format
Executive - Regulatory Affairs
LG Life Sciences
Documentation for Import and Registration of Bio-medical products and medical devices in India
Compilation and submission of dossiers as per Indian regulatory guidelines and handling queries
Providing technical and regulatory information support to LG Life Sciences, Korea
Successfully faced Local FDA Audits
Trainee Executive - Quality Control
Torrent Pharmaceuticals Ltd
Preparation of documents as per cGMP, ISO 17025:2005 and as per in-house guidelines
Preparation of QMS documents like Quality Manual, Quality Procedures & Quality Formats
Managing communication with NABL Accreditation body
Successfully faced the NABL AuditHonors & Awards
Gold Medalist
Education
Bioinformatics Institute of India
Post Graduate Diploma, Pharmaceutical Regulatory Affairs
- https://in.linkedin.com/in/kbudhiraja
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