Snehal Kandalkar
@snehalkandalkar
Proactive and detail-driven Regulatory Affairs Executive
What I'm looking for
As a seasoned Regulatory Affairs Executive with over a year of experience, I have honed my skills in managing and compiling high-quality dossiers for regulatory submissions across ROW markets. My expertise lies in leading cross-functional teams, prioritizing tasks, and delivering results that meet project and client expectations. I am adept at project planning, financial forecasting, and risk management, with a strong focus on regulatory compliance, client-focused consulting, and project management.
Throughout my career, I have demonstrated my ability to efficiently manage multiple regulatory projects, address complex issues, and respond promptly to dossier-related queries. I have also developed strong liaison skills, assisting in communication with clients to gather necessary information and documents for regulatory submissions.
I am committed to staying updated on regulatory changes, assessing risks, and providing strategic insights for compliance and business support. My expertise in lifecycle management, summary and leaflet preparation, and CTD compilation has enabled me to make significant contributions to my previous roles.
Experience
Work history, roles, and key accomplishments
Regulatory Affairs Executive
AR Lifesciences
Mar 2023 - Present (2 years 2 months)
Managed multiple regulatory projects, addressed complex issues, and responded promptly to dossier-related queries. Coordinated with clients to gather necessary information and documents for regulatory submissions.
Regulatory Affairs Officer
AR Lifesciences
Sep 2022 - Mar 2023 (6 months)
Drafted, compiled, and finalized quality dossiers for ROW markets, ensuring compliance with country-specific formats. Coordinated with cross-functional teams to prioritize work, integrate regulatory requirements into product development, and meet project milestones.
Education
Degrees, certifications, and relevant coursework
Snehal hasn't added their education
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