We are seeking a highly motivated and detail-oriented Regulatory Affairs Executive/Senior Executive with approximately 5 years of experience in Formulation Regulatory Affairs to manage regulatory submissions and lifecycle activities across LATAM, MENA, and Asia-Pacific markets. The candidate will be responsible for dossier compilation, submission, deficiency responses, product registrations, and post-approval variations while ensuring compliance with country-specific regulatory requirements and timelines.

Key Responsibilities
Regulatory Submission Management
Prepare, review, compile, and submit dossiers in CTD/eCTD/ACTD formats for registration of pharmaceutical products in LATAM, MENA, and Asian countries.
Coordinate preparation of Module 1 to Module 5 documentation in collaboration with cross-functional teams (R&D;, QA, QC, Manufacturing, Medical Affairs, Supply Chain, and Project Management).
Ensure timely submission of recent registrations, renewals, variations, notifications, and line extensions.
Handle dossier customization as per country-specific regulatory requirements.




Health Authority & Customer Query Management
Review and respond to regulatory deficiency letters, health authority queries, and customer questionnaires within stipulated timelines.
Coordinate with CMC, Analytical Development, Stability, Quality, and Manufacturing teams to obtain required supporting data.
Track query responses and ensure successful closure of regulatory observations.

Market-Specific Regulatory Support
Manage product registrations and lifecycle maintenance for countries within:
LATAM: Brazil, Mexico, Chile, Peru, Colombia, Ecuador, Central America, etc.
MENA: Saudi Arabia, UAE, Jordan, Iraq, Kuwait, Oman, Qatar, Bahrain, Egypt, Morocco, Algeria, etc.
Asia: Philippines, Thailand, Vietnam, Malaysia, Singapore, Indonesia, Cambodia, Hong Kong, South Korea, Taiwan, etc.
Ensure compliance with country-specific regulations and changing regulatory requirements.
Lifecycle Management
Prepa

📌 Executive / Senior Executive – Formulation Regulatory Affairs (LATAM, MENA & Asia Markets) (Hyderabad)
🏢 Granules India
📍 Hyderabad