Job Description:

ompile, author, and maintain Type III Drug Master Files (DMF) for the US FDA, Health Canada, and equivalent
regulatory submission dossiers for European (EDQM) and Asian regulated agencies.
Coordinate the preparation of comprehensive technical dossiers covering raw materials, master-batch
compounding matrices (Halobutyl polymers), formulation ingredients, and vulcanization traits.
Manage the swift completion of annual DMF reports, regulatory updates, and formal letters of authorization
(LOA) for pharmaceutical clients incorporating our products into their drug applications.
2. Compendial & Regulatory Market Compliance
Ensure all rubber formulations and components comply with international compendial parameters including
USP <381> / USP <382>, EP 3.2.9, JP 7.03, and overarching container guidelines under ISO 8871.
Govern full product alignment with environmental safety guidelines including REACH, RoHS, and food-contact
provisions (FDA 21 CFR 177.2600) for general rubber applications.
Review and sign off on complex scientific reports for Extractables and Leachables (E&L;), Container Closure
Integrity (CCI), needle-penetration force, self-sealing traits, and fragmentation profiling.
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📌 Regulatory Affairs Manager (Kheda)
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