Website Amneal pharma ltd
Post Name: Executive, Regulatory Affairs
Key Responsibilities:
1. Dossier Preparation & Submissions
Prepare, review, and submit CTD / ACTD / country‑specific dossiers for: New product registrations
Line extensions (strength, pack size, shelf life)
Variations and renewals
Coordinate compilation of Modules 1–5 with QA, QC, R&D, CMC, PV, PM, and Manufacturing teams.
Ensure dossier compliance with WHO, ICH, and local authority guidelines.
2. Regulatory Strategy & Market Support
Support business development by providing regulatory feasibility and timelines for new markets/products.
Assess regulatory impact for formulation/site changes.
3. Regulatory Lifecycle Management
Manage post‑approval changes, including: CMC variations
Labeling updates
Artwork changes
Track and ensure timely renewals/re‑registrations.
Maintain approved product documentation and regulatory databases.
4. Health Authority Interaction
Handle deficiency letters / queries from regulatory agencies.
Prepare responses in coordination with internal stakeholders.
Liaise with local agents, consultants, and partners for RoW countries whenever required.
5. Compliance & Intelligence
Monitor regulatory guideline updates for RoW markets.
Ensure submissions comply with the latest country requirements.
Markets Typically Covered (RoW)
LATAM: Brazil, Mexico, Colombia, Peru, Chile, Guatemala
MENA/GCC region
CIS: Russia, Ukraine, Kazakhstan, etc.
ASEAN: Philippines, Vietnam, Thailand, Malaysia, etc.
Qualifications:
Required Qualifications & Experience:
• Educational Background:
o M.Pharm / B.Pharm
• Experience:
o 3-9 years in Pharmaceutical Regulatory Affairs
