Executive, Regulatory Affairs

• 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.

• Support business development by providing regulatory feasibility and timelines for new markets/products.
• Assess regulatory impact for formulation/site changes.

• 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.

• 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.

• Monitor regulatory guideline updates for RoW markets.
• Ensure submissions comply with the latest country requirements.

• LATAM: Brazil, Mexico, Colombia, Peru, Chile, Guatemala
• MENA/GCC region
• CIS: Russia, Ukraine, Kazakhstan, etc.
• ASEAN: Philippines, Vietnam, Thailand, Malaysia, etc.

Required Qualifications & Experience • Educational Background: o M.Pharm / B.Pharm • Experience: o 3-9 years in Pharmaceutical Regulatory Affairs