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Amneal Pharmaceuticals
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Executive, Regulatory Affairs

Executive, Regulatory Affairs

Amneal Pharmaceuticals

1 - 6 years

3 - 8 Lacs

Ahmedabad

Posted:2 months ago| Platform:

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Skills Required

QA CRO Project development QC Executive Regulatory Affairs qaqc product life cycle Database Monitoring Technical documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Compilation & Review of quality ANDAs for General and Complex Injectable Products within timeline. Compilation and review of Amendments (DRL/IR/CR) within stipulated timeline for Amneal Injectable products. Review of technical documents of PD, ARD, QA, QC, Production and CRO to include as a part of Dossier. Follow up with cross-functional team for completion of assigned technical and regulatory task. Preparation of regulatory strategy/white papers and to include any critical/important missing points and finalization in consultation with superior. Primary review of DMFs of General and Complex Injectable API and follow up with purchase team for vendor documentation. Preparation and review of Controlled Correspondences for General and Complex Injectable products. Communication and discussion with CMOs for outside development projects. Co-ordination with R&D, ARD, QC, QA, Clinical, Labeling team for any outstanding technical task and escalation with superiors for resolution. Monitoring the change in regulations, regulatory procedures & guidances and to evaluate impact on product life cycle. Preparation and archival of global regulatory database.

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Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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Executive, Regulatory Affairs