Deputy Manager - Regulatory Affairs

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Piramal Critical Care Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

For more details, please visit https://www.piramalcriticalcare.com/global/

Job Title

Deputy Manager - Regulatory Affairs Job Description

Publishing and dispatching eCTD submissions for EU-(Human, Vet), TGA, US FDA (Human, Vet), UK (Human, Vet), Canada and GCC countries through established gateways. Document level publishing, document issue resolution, and quality control checks; managing EU and US submissions across the product lifecycle, from initial filings to variations and periodic safety update reports (PSURs). 1) Responsible for publishing and dispatching 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.

2) Managed preparation of US Veterinary submission packages using the CVM Submissions Portal.

3) Responsible for document‑level publishing, document issue resolution, and quality control checks to deliver agency‑compliant submission documents.

4) Experience managing EU and US submissions across the product lifecycle, from initial filings to variations and periodic safety update reports (PSURs) and manages responses.

5) Experienced in managing Initial submission publishing and ensuring the successful transmission of high‑quality, agency‑compliant submissions.

6) Knowledge of ICH and eCTD specifications for regulatory submissions (eCTD, NeeS, paper, VNeeS).

7) Experienced in working with technical platforms like Pharmaready, Adobe Acrobat, DXC Tool Box, and Lorenz Docubridge.

8) Submission of safety reports, ANDA filings, and annual reports to the FDA through the ESG NextGen portal as required.

9) Ensure comprehensive product life cycle information is maintained within the database.

10) Prepare eSubmissions by bookmarking, hyperlinking, and ensuring PDFs comply with Health Authority (HA) guidelines.

11) Work with teams to develop and refine departmental SOPs.

12) Develop Standard Work Instructions (SWI) for newly implemented tools.

13) Ensure timely circulation of submission and approval notification updates to the PCC team while maintaining a tracker for status management.