Regulatory affairs

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

Candidates with experience in Formulation QA RA, Analytical, Formulation R&D, and interested in advancing their career in RA ROW, are encouraged to apply.

Plans and coordinates activities to ensure regulatory lifecycle management activities and approvals are achieved by the Local Operating Company in a timely manner for all globally approved products.

Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management. Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities

To file amendments and deficiency response within timelines with go getter approach. The job requires review of documents related to DMF submission against predefined checklists and submission to various agencies globally.

eCTD Compilation, validation, and submission to Health Canada and US through ESG gateway for New Submission ANDS, NDS, Deficiencies response Clarifax, SDN, NOD, NON, Supplements submissions