I
Intas
Assistant Manager
Skills
Compliance
1 month ago
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Important information
Contract type:
Permanent
Location:
Ahmedabad, Gujarat, India
Work mode:
Onsite
Published on:
11 September 2026
What they need
- Evaluation of change control request receiving from all the cross-functional teams.
- Co-ordinating with the all the cross-functional teams to arrange the documents as mentioned & generated as per the change control request.
- Review of all documents required for variation filing ensuring its accuracy & adequacy.
- Timely highlight the concerns /issues/non-compliance to the reporting manager
- Submission, review & Monitoring the submission of Type IAIN, IA, IB and II European variations of solid oral dosage forms to regulatory agencies.
- Submission, review & Monitoring of Regulatory variation deficiencies.
- Monitoring the variation approvals.
- To carry out additional activities related to the regulatory department as and when required.
- To follow GMP Compliance and procedure as per the respective SOPs.
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