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Team Member

1 month ago

Vikhroli Mumbai Maharashtra, India Cipla Full time

**Division**:

- IPD

**Department**:

- IPD

**Employment Type**:

- Permanent

**Job Purpose**:
Submit product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the products life-cycle

**Accountabilities**:
I. Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time
III. Maintain, and update product dossier as required to meet changes in Ciplas internal systems, changes in regulatory guidelines, and to meet the need of regulatory requirements
IV. Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in database.
V. Provide Regulatory support throughout the life cycle of the product for smooth functioning
VI. Provide the informatuitability and availability of dossier for out-licensing and in-licensing
VII. Check with regulatory authorities (EU, NZ & TGA) for submission activity and approval status for submission done

**Education Qualification**:
B.Pharmacy, M. Pharm, Bsc or MSc

**Relevant Work Experience**:
Minimum 5 years' experience in regulatory activity in pharma industry preferably worked for same region/authority

**Competencies/Skills**:

- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management

**Job Location**:
Vikhroli

**Shift Hours**: