Manager - Regulatory Affairs Formulation (ROW Market)

MSN Group; Hyderabad; On-site; INR 2,800,000 - 5,000,000; Full time

Job summary

MSN Group in Hyderabad, India seeks a Manager Regulatory Affairs Formulation (ROW Market) to lead regulatory dossier management and global submissions. You will coordinate CTD/eCTD/ACTD filings, review modules, ensure country-specific compliance, and manage registrations for tablets, capsules, injectables, and other dosage forms across ROW markets.

Ideal candidates have 12–16 years in regulatory affairs, with hands-on experience in formulation dossiers and coordinating with R&D, QA/QC, and

Qualifications

• M.Pharm in Pharmaceutics is required; additional regulatory affairs certification is an advantage.
• 12–16 years of experience in Pharmaceutical Regulatory Affairs with ROW submissions.

Responsibilities

• Prepare, review and manage CTD/eCTD and ACTD dossiers for ROW markets.
• Review Modules 1–5 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 from Formulation R&D, Analytical R&D, QA and QC.
• Handle product registration activities across ROW countries (Africa, CIS, ASEAN, LATAM, Middle East).
• Understand and implement country-specific regulatory requirements.
• Manage new product registrations, renewals, variations, post-approval changes.
• Respond to queries from regulatory authorities and coordinate with local agents/distributors/consultants.
• Ensure compliance with WHO-GMP, ICH guidelines and country-specific regulations; monitor updates; maintain databases and submission tracking.

Skills

CTD/eCTD ACTD dossier prep

ROW regulatory guidelines

Product registration lifecycle

Regulatory query management

ICH WHO-GMP knowledge

Pharmaceutical formulation knowledge

Regulatory docs management

Education

M.Pharm Pharmaceutics

Regulatory affairs certification (advantage)

Tools

MS Office

Regulatory documentation systems

Job description

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 new 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.