Ira India

18 hours ago

Ahmedabad Gujarat, India Zydus Group Full time

Department
- IRA
- Job posted on
- Nov 10, 2025
- Employee Type
- P-P8-Probationer-HO Executive
- Experience range (Years)
- 5 years - 9 years

- **Digitalization**:
To ensure timely compliance with DCGI’s recent guideline on digitalization of WHO certificate, COPP and other related activities.

1. Registration of all the sites of Zydus (65 nos.) on ONDLS portal, Mapping of All licenses (120 nos.), WHO certificates (20 nos.) and permissions (9000 nos.) on portal.

2. Evaluation and compliance of mismatch between offline and online granted approvals (Approx. 9000 approvals).

- **Medical Device**:
Considering recent acquisition of Nano Medical device plant, Brazil TAVI project and upcoming SEZ medical device facility, regulatory workload is set to increase significantly.

1. Mfg. Lic.

2. Import Lic.

3. MSC/NCC certificates

4. FSC certificate

5. Wholesale Licence management

- **CDSCO and FDCA related filings**:
1. Licence activity outside Gujarat state

2. Direct to consumer (Zydus online Platform) portfolio

3. Support in regulatory filings like Export NOC, commercial products approval, WHO GMP certificates, Import Licence etc.

4. Pharmacopeia Implementation within all sites of Zydus

- **Third party product’s portfolio: (Under discussion)**
- To review and approve P2P product’s (Approx. 150 nos.) AIF and Artworks.

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