Dharmik Upadhyay
Summary
Experienced Regulatory Affairs professional with over two years of experience managing regulatory submissions and ensuring compliance with domestic regulatory standards. Skilled in documentation, communication with authorities, and cross-functional collaboration. Actively pursuing opportunities to leverage expertise in highly regulated global markets.
Overview
3
3
years of professional experience
Work History
Volunteering
Lawlor Pharmasave
10.2024 - Current
- Learning basic skills of pharmacy operations, third party billing, dispensing the medications and processing the prescriptions on Kroll software, making compliance packaging, managing inventory and checking out expiry medications, cash-out and associating in over-the-counter section
Regulatory Affairs Executive
Intas Pharmaceuticals
07.2022 - 10.2024
- Prepared Nepal dossier for new product registration as well as renewal of product
- Reviewed label/carton Artworks for domestic and export market
- Reviewed, prepared and submitted of BENOC, TL application and Query Response for BE study with help of SUGAM portal
- Post Approval changes applications such as Amendments (PI Change/Site Addition/Site change), Study updates and Notification for BA/BE study
- Prepared and submitted Import License application: Form 11/Form CT-16 for Finished Product & API
- Prepared and submitted Test License application: Form CT10/CT-12/CT-13 applications
- Prepared and submitted of FDA related applications such as Form 29, Product permission for Export and Domestic Market
- Collaborated with cross-functional teams, including R&D and QA, to align regulatory strategies with product development goals
- Coordinated with regulatory authorities to resolve queries and ensure timely approvals
Education
Masters of Pharmacy - Regulatory Affairs
Gujarat Technological University
05.2022
Bachelors - Pharmacy
Gujarat Technological University
07.2019
Skills
- Knowledge of regulatory guidelines like ICH, FDA & EMA
- Regulatory submissions and compliance
- Monitoring of Regulatory Developments
- Project management and timeline adherence
- Documentation preparation and quality review
- Strong Organizational and Time
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Interpersonal skills
- Executive support
- Client-Focused
- Supportive Team Participant
Languages
English
Hindi
Gujarati
Hobbies and Interests
- ECTD Publishing
- Dossier Filling
- Regulatory submission
- Regulatory review in USA/Canada/EU market
Timeline
Volunteering
Lawlor Pharmasave
10.2024 - Current
Regulatory Affairs Executive
Intas Pharmaceuticals
07.2022 - 10.2024
Bachelors - Pharmacy
Gujarat Technological University
Masters of Pharmacy - Regulatory Affairs
Gujarat Technological University
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