Assistant Regulatory Affairs Manager
3 days ago
Company brief
Since 1980, Octavius Pharma has been empowering lives through its high quality technologically driven diverse range of products. Over the years, Octavius has expanded its product portfolio & operations in different market segments worldwide.
As a global leader in pharmaceutical products and direct compressible granules, we develop products at our state-of-the-art R&D facility as per latest Pharmacopoeia. Our global portfolio includes direct compressible granules, finished dosage formulations, nutraceuticals / food supplements in various ROW markets
Description
To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all Latam and CIS, ROW Countries and other country as per company requirements. Responsible for final review of dossier before submission. To coordinate with technical team for documents required for dossier. Responsible to gather data related for dossier through online sources, laboratories, manufactures etc. Reviewing artwork for products as per relevant regulatory authority requirements. To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. Lead and train junior regulatory staff, encourage cross-market knowledge-
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