Role & responsibilities

Job Title

Manager Regulatory Affairs Formulation (ROW Market)

Key Responsibilities

Regulatory Dossier Management

- Prepare, review and manage CTD/eCTD and ACTD dossiers for ROW markets.
- Review Module 1, 2, 3, 4 and 5 documentation, as applicable.
- Ensure regulatory documents comply with country-specific guidelines.
- Coordinate preparation of registration dossiers for tablets, capsules, injectables, liquid orals and other dosage forms.
- Review technical documents received from Formulation R&D;, Analytical R&D;, QA and QC.

ROW Market Regulatory Activities
- Handle product registration activities across ROW countries, including Africa, CIS, ASEAN, LATAM and Middle East markets.
- Understand and implement country-specific regulatory requirements.
- Manage current product registrations, renewals, variations and post-approval changes.
- Respond to queries raised by regulatory authorities.
- Coordinate with local agents, distributors and regulatory consultants.

Regulatory Compliance
- Ensure compliance with WHO-GMP, ICH guidelines and applicable country-specific regulations.




- Monitor regulatory updates and assess their impact on existing products.
- Maintain regulatory databases and submission tracking systems.
- Ensure timely submission of regulatory documents and responses.

Educational Qualification
- M.Pharm Pharmaceutics,
- Additional regulatory affairs certification will be an advantage.

Required Experience
- 12-16 years of experience in Pharmaceutical Regulatory Affairs.
- Relevant experience in ROW market regulatory submissions.
- Experience in formulation dossier preparation and product registration.
- Prior experience handling regulatory teams and multiple international markets.

Technical Skills Required
- CTD/eCTD and ACTD dossier preparation.
- ROW country-specific regulatory guidelines.
- Product registration and lifecycle management.
- Regulatory query management.
- ICH, WHO-GMP and stability guidelines.
- Pharmaceutical formulation and manufacturing knowledge.
- MS Office and regulatory documentation management.

📌 Manager - Regulatory Affairs Formulation (ROW Market) (Hyderabad)
🏢 MSN Group
📍 Hyderabad