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

- Solid 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.

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