Officer/Executive - RA
2 days ago
Responsibilities:
- Compilation and review of regulatory dossiers (CTD, ACTD, eCTD) for CIS, LATAM (especially Brazil & Mexico), African, and EU regions.
- Handle full lifecycle of product registration including new submissions, renewals.
- Review technical documentation: PDR, DMF, AMV, BMR/BPR, Specifications, Stability Reports, BE Studies, etc.
- Address Ministry of Health (MoH) queries and manage deficiency responses.
- Manage post-approval changes and variation submissions.
- Liaise with international regulatory agents and distributors for submission coordination.
- Artwork review and approval ensuring compliance with label regulations.
- Maintain up-to-date registration database and submission tracker.
- Prepare administrative documents: POAs, LOAs, legalization support, etc.
- Conduct compliance review for change controls, tech transfer documents, and CMO
- Support site registration and GMP audits when required.
- Review and finalize Quality Agreements with partners/clients.
- Handle pharmacovigilance documentation (via third-party support).
Required Skills:
- Expertise in CIS, LATAM, EU, and African regulatory landscapes.
- Strong understanding of regulatory systems (e.g., ANVISA, EMA, CDSCO).
- Prior QC/analytical lab experience (esp. with HPLC) is a plus.
- Proficient in regulatory writing and dossier compilation independently.
- Strong coordination, analytical, and document management skills
Required Qualification: - B.Pharm/M.Pharm
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