Support compliance documentation activities related to computer systems, including review coordination, evidence collection, document quality checks, and maintenance of controlled documentation.
Drive for self-development, the ability to collaborate, and an action-oriented work ethic. Strong communication skills with the ability to distil complex information into clear, actionable insights for clients.
BDR Pharmaceuticals International Pvt Ltd and BDR Life sciences Pvt. Ltd, each one having stamped its own supremacy in respective fields, i.e. API and formulation manufacturing, respectively.
B.Sc. degree in Life Science/Pharmacy or equivalent/related discipline or certification in a related allied health profession from an appropriately accredited institution
Collaborate with peers across the organization to achieve client-centric delivery in a matrix organization. Collaboration across all stakeholders within Site Readiness
Responsible for identifying and developing new business opportunities in Pharmaceutical Contract Manufacturing (CMO), Loan License Manufacturing (LLM), and R&D services for USA, CANADA, EU, UK and ROW Market.
Perform analysis of ointment, cream, gel, solution, raw material, and stability samples. Hands-on experience with HPLC, UPLC, GC, UV, IR, pH, viscosity, and assay testing.
This role focuses on managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. You will partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.