Sunny Panwar
Angestellt, Senior Associate Regulatory Affairs, ClinChoice Inc
Abschluss: Master of Pharmacy, Amity University, India
Berlin, Deutschland
Über mich
Senior Associate in Regulatory Affairs with extensive experience in managing regulatory compliance for medical devices, IVDs, pharmaceuticals, and cosmetics. Working knowledge of EU MDR, EU IVDR, US FDA Medical Device Regulations and CFR 21. Proven track record of successfully leading regulatory submissions and coordinating with cross-functional teams. Expertise in developing and implementing regulatory action plans, monitoring, and escalating issues, and ensuring compliance with country-specific regulations. Strong understanding of technical data, administrative/legal documents, and device master files. Skilled in preparing and submitting import licenses, test licenses, and amendment of IVDD licenses.
Werdegang
Berufserfahrung von Sunny Panwar
- Developed and managed regulatory action item tables to ensure compliance with country-specific requirements. - Incorporated follow-up items and implemented ongoing monitoring and issue escalation processes to ensure successful project deliverables. - Ensured the quality review of documents before submission to health authorities to ensure submission readiness. - Coordinated with cross-functional teams to collate labels and COA's of API, excipients and finished products to support product portfolio.
1 Jahr und 3 Monate, Feb. 2021 - Apr. 2022
Regulatory Affairs Associate
Roche Diagnostics India Ltd
- Worked through the entire regulatory lifecycle of a product. - Worked on internal document requisition portal “Regulatory Information Management System (RIMS)” to requisition, prepare, and track product documents. - Handled multiple global projects involving digital health, RIMS, safety reporting, and post-approval changes. - Participated in the policymaking and enforcement of MDR-2017 and other related Rules as per Roche Policy - Working knowledge of MDR 2017, EU MDR, EU IVDR, US FDA and ISO 13485.
7 Monate, Juni 2019 - Dez. 2019
Regulatory Affairs Associate
Unicure India Ltd
- Monitored and analyzed relevant regulatory activities for compliance - Prepared and submitted applications for generic drug manufacturing - Regularly followed up with Licensing Authorities and coordinated with in-house departments for "Tech Transfer" - Led regulatory submissions for completeness, accuracy, and compliance with agency regulations and mitigated product development risks.
9 Monate, Sep. 2018 - Mai 2019
Regulatory Affairs Associate
Accredited Consultants Pvt Ltd
- Proactively planned for all regulatory submissions based on business requirements and new requisitions from Business Area (BA) - Well-versed with regulatory requirements of Non-IVDDs and IVDDs and ISO 13485. - Gained understanding of technical data, administrative/legal documents, Device Master File, Plant Master File received from different countries for submission to Indian Regulatory Agency. - Drafted regulatory/administrative documents for submissions of application.
Ausbildung von Sunny Panwar
2 Jahre, Juni 2016 - Mai 2018
Drug Regulatory Affairs
Amity University, India
4 Jahre, Mai 2012 - Apr. 2016
Bachelor of Pharmacy
Abdul Kalam Technical University, Lucknow
Sprachen
Englisch
Fließend
Deutsch
Grundlagen
HINDI
Muttersprache