Executive- DRA

SAVA Group; Maharashtra; On-site; INR 600,000 - 1,200,000; Full time

Job summary

SAVA Group in India (Maharashtra) seeks a Regulatory Affairs professional to prepare, compile, and submit CTD/eCTD dossiers for ROW and EU markets, ensuring compliance with regulatory guidelines. The role involves coordination with QA, QC, Production, and R&D to assemble required documentation.

You will handle variation and renewal dossiers, track regulatory submissions, respond to deficiency queries within timelines, and support audits and inspections with strong documentation and timeline

Qualifications

• 2–5 years of experience in Regulatory Affairs.
• Hands‑on experience in ROW and EU dossier preparation.
• Experience in handling variations and renewals.
• Strong knowledge of CTD/eCTD format.
• Understanding of EU and ROW regulatory guidelines.

Responsibilities

• Prepare and compile CTD/eCTD dossiers for ROW and EU markets.
• Review and verify technical documents (Module 1–5).
• Coordinate with QA, QC, Production, R&D, and other departments for required documentation.
• Ensure submissions comply with guidelines of regulatory authorities such as EMA and country regulations.
• Handle deficiency queries and prepare responses within timelines.

Skills

Attention to detail

Documentation

Coordination

Communication

Education

B.Pharm / M.Pharm / B.Sc / M.Sc (Life Sciences)

Tools

MS Office

Regulatory software tools

Job description

To support the Regulatory Affairs function by preparing, compiling, and submitting dossiers for ROW (Rest of World) and EU markets, handling variations, and managing renewals in compliance with applicable regulatory guidelines.

Key Responsibilities

Preparation and compilation of CTD/eCTD dossiers for ROW and EU markets.

Review and verification of technical documents (Module 1–5).

Coordination with QA, QC, Production, R&D, and other departments for required documentation.

Ensuring submissions comply with guidelines of regulatory authorities such as European Medicines Agency and respective country regulations.

Handling deficiency queries and preparing responses within stipulated timelines.

2. Variation Management

Preparation and submission of variation dossiers (Type IA, IB, Type II as applicable).

Tracking variation approvals and implementation timelines.

Maintaining updated records of approved variations.

3. Renewals

Preparation and submission of renewal dossiers within regulatory timelines.

Coordination for updated documents required for renewals.

Tracking renewal status and maintaining regulatory database.

4. Regulatory Compliance & Documentation

Maintaining regulatory trackers and submission databases.

Supporting audits and inspections related to regulatory documentation.

Educational Qualification

B.Pharm / M.Pharm / B.Sc / M.Sc (Life Sciences)

Experience

2–5 years of experience in Regulatory Affairs.

Hands‑on experience in ROW and EU dossier preparation.

Experience in handling variations and renewals.

Strong knowledge of CTD/eCTD format.

Understanding of EU and ROW regulatory guidelines.

Good documentation and coordination skills.

Attention to detail and timeline management.

Proficiency in MS Office and regulatory software tools.