Deputy Manager - Regulatory Affairs

Overview

Publish and dispatch eCTD regulatory submissions across EU, US, UK, TGA, Canada and GCC markets for Piramal Critical Care, managing submissions across the product lifecycle.

What you'll do

• Publish and dispatch eCTD submissions for EU (Human, Vet), TGA, US FDA (Human, Vet), UK (Human, Vet), Canada and GCC countries through established gateways including CESP, ESG NextGen, Syncplicity and MHRA Portal.
• Prepare US Veterinary submission packages using the CVM Submissions Portal.
• Perform document-level publishing, document issue resolution, and quality control checks to deliver agency-compliant submission documents.
• Manage EU and US submissions across the product lifecycle, from initial filings to variations and periodic safety update reports (PSURs), and manage responses.
• Manage initial submission publishing and ensure successful transmission of high-quality, agency-compliant submissions.
• Submit safety reports, ANDA filings, and annual reports to the FDA through the ESG NextGen portal as required.
• Maintain comprehensive product life cycle information within the database.
• Prepare eSubmissions by bookmarking, hyperlinking, and ensuring PDFs comply with Health Authority (HA) guidelines.
• Work with teams to develop and refine departmental SOPs.
• Develop Standard Work Instructions (SWI) for newly implemented tools.
• Ensure timely circulation of submission and approval notification updates to the PCC team while maintaining a tracker for status management.

What you'll need

• Knowledge of ICH and eCTD specifications for regulatory submissions (eCTD, NeeS, paper, VNeeS).
• Experience working with technical platforms such as Pharmaready, Adobe Acrobat, DXC Tool Box, and Lorenz Docubridge.