
Sunny Panwar
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Sunny Panwar
- Bis heute 1 Jahr und 7 Monate, seit Jan. 2024
Senior Regulatory Affairs Associate
Roche Diagnostics Asia Pacific Pte Ltd
Worked through the entire regulatory lifecycle of a product in Molecular Diagnostics, Companion Diagnostics (CDx), Tissue Diagnostics, Point of Care (PoC) / Near Patient Tests (NPT), and SARS CoV-2 products (COVID-19 test kits) for regulatory submissions of Import License Applications, Test License Applications
- 1 Jahr und 9 Monate, Apr. 2022 - Dez. 2023
Senior Associate Regulatory Affairs
ClinChoice Inc
- 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
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