Sunny Panwar

is working from home. 🏡

Angestellt, Senior Regulatory Affairs Associate, Roche Diagnostics Asia Pacific Pte Ltd
Abschluss: Master of Pharmacy, Amity University, India
Berlin, Deutschland

Fähigkeiten und Kenntnisse

ISO 13485
FDA
ISO
Technical Documentation
GMP
Compliance
Quality Management
ISO 9000
CAPA
Audit
IVD Regulations
Medical device
IVDR
MDR
German
Biology
Legal rule
Consulting
Pharmaceuticals
MS Office

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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