Posted:3 hours ago|
Platform:
Work from Office
Full Time
1. Compilation of various applications like CC / CGT / iPSP / PIND packages.
2. The planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2/ANDA/PAS submissions including FDA meeting requests and technical DS, DP and Clinical packages.
3. Compilation and review of Labeling and SPLs for NDA/ANDA/PAS applications.
4. Review and compilation of DMF sections for NDA/ANDA/PAS filing.
5. Ensures that project timelines are developed and communicated; evaluates changes to maintain submission goals and timelines; communicates any delays along with the rationale.
6. Updates of status and trackers of Regulatory submission.
2. Strong analytical skills; Operational activities and product launches in generics.
3. Cross-functional collaboration skills with the ability to network with different functional areas and integrate cross-functional deliverables.
4. Sterile injectable and Solid Oral Dosage form registration experience candidates are required.
5. Proficiency in eCTD software, SPL, MS Office & MS Project.
6. Strong oral interpersonal and written communications skills.
Nivagen Pharma (india)
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