Deputy Manager - Regulatory Affairs
MumbaiFull-timeMid levelPosted 1 week ago
Mid-level pharma role at Piramal Pharma in Mumbai.
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