DRA

Plan and coordinate with various departments like QA, QC and Production, to project the document requirements for appropriate submissions. Co-ordination with clients for the tracking and status update of project plans.

Author Safety Data Sheets for multiple geographies across the globe as per applicable hazard communication regulations. Derive hazard classifications for substances and mixtures using various classification regulations including but not limited to GHS, CLP, and OSHA Hazard Communication Standard.

B.Pharmacy, M. Pharm, Bsc or MSc; Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time

Biochemical analysis such as protein content, sodium metabisulphite testing, HPLC, and sample management include receiving in-process samples, final bulk and final lot samples, distribution, and storage under appropriate storage conditions.

Regulatory Submissions Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and regulations. API Equipment Handling.

Ensure the on-time filing of high-quality regulatory submission, and to assist in the preparation, maintenance, and control of regulatory dossiers. Interact with Regulatory agency on regulatory submissions and follow up for drug product approvals.

Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market. Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action. Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions

Skilled in process validation document preparation and review, with strong knowledge of QMS, qualification documents, regulatory audits, and vendor qualification and audits in a regulated environment.