Executive / Senior Executive – Formulation Regulatory Affairs (LATAM, MENA & Asia Markets)

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 new 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
Prepare and submit:
Variations/Amendments
Renewals/Re-registrations
Site Transfers
Manufacturing Changes
Packaging Changes
Source Changes
Shelf-life Extensions
Assess change controls and regulatory impact on marketed products.
Regulatory Intelligence & Compliance
Monitor evolving regulatory requirements, guidelines, and market-specific updates.
Evaluate regulatory changes and communicate impact to internal stakeholders.
Maintain compliance with current ICH, WHO, FDA, EMA, ANVISA, SFDA, HSA, NMPA, and other applicable regulatory requirements.
Documentation & Tracking
Maintain regulatory databases, product registration trackers, and submission schedules.
Ensure proper version control and archival of regulatory documents.
Support regulatory audits and inspections by providing required documentation.
Hands-on experience in dossier preparation and submissions for regulated and semi-regulated markets.
Exposure to LATAM, MENA, and Asia market registrations is preferred.
Technical Skills
Strong understanding of:
CTD/eCTD/ACTD dossier formats
ICH guidelines
Stability requirements
Pharmaceutical development documentation
CMC regulatory requirements
Product lifecycle management
Knowledge of country-specific submission requirements across LATAM, MENA, and Asia.
Key Competencies
Strong regulatory writing and dossier compilation skills.
Excellent communication and stakeholder management abilities.
Ability to manage multiple submissions and strict timelines.
Analytical thinking and problem-solving skills.
Attention to detail and compliance-focused mindset.
Effective cross-functional coordination abilities.

Work arrangement
No