Asmat Ibtesham Ansari
Regulatory Affairs Specialist | Expertise in CTD/ACTD Dossier Preparation, Compliance and Customer/MoH Co-ordination| Strong in Cross-Departmental collaboration & Regulatory Submissions| CMC Review | DCP | MAA| Variation
- Role
- Assistant Manager at Olive PharmaScience Ltd
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Asmat Ibtesham Ansari
I am a dedicated professional in Regulatory Aairs with extensive experience in preparing…
Experience
Assistant Manager
Aug 2019 — Present · Mumbai, IN
Olive PharmaScience Limited is a fully integrated developer, manufacturer of broad range of soft gelatin formulations• Author and review regulatory CMC submissions including new registrations, variations, renewals, and responses to agency queries• Ensure accuracy and regulatory compliance of technical documentation and drive timely fulfillment of CMC-related commitments• Represent CMC on project teams, oversee project execution, and manage assigned regulatory portfolios with minimal supervision• Provide expert advice and implement regulatory strategies to support product development and commercialization.• Collaborate with R&D, Quality, and Regulatory Affairs teams to align on submission content and timelines.• Communicate with clients via email or phone to gather necessary information and ensure project progress.• Act as the designated nominee signatory for FSSAI audits, responsible for obtaining the Food Safety and Standards license and filing the annual return.• Managed Test License, NOC applications, and import permits through the NSWS/Sugam Portal to ensure compliance with regulatory requirements for pharmaceutical imports.• Assist the raw material procurement team in reviewing vendor qualification documents.• Mentor junior team members and contribute to broader regulatory or organizational initiatives as needed• Independently resolve cross-functional issues to maintain project eciency.
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