Deputy Manager - Regulatory Affairs

About the role

Publishing and dispatching eCTD submissions for EU-(Human, Vet), TGA, US FDA (Human, Vet), UK (Human, Vet), Canada and GCC countries through established gateways.

What you'll do

• Responsible for document‑level publishing, document issue resolution, and quality control checks to deliver agency‑compliant submission documents
• Ensure comprehensive product life cycle information is maintained 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

What you need

• Regulatory affairs
• Quality control
• SOP writing
• ICU care
• Any graduate