The Role
Supports Regulatory Affairs by preparing and submitting CTD/eCTD dossiers for EU and ROW markets. Manages variations, renewals, deficiency responses, regulatory trackers, submission databases, document archiving, and audit support. Coordinates with QA, QC, Production, R&D, and other departments to ensure complete and compliant documentation. Requires knowledge of EU and international regulatory guidelines, strong documentation skills, attention to detail, and timeline management.
Summary Generated by Built In
Job Purpose
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 Responsibilities1. Dossier Preparation (ROW & EU)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 ManagementPreparation 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. RenewalsPreparation 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 & DocumentationMaintaining regulatory trackers and submission databases.
Ensuring document archival as per SOPs.
Supporting audits and inspections related to regulatory documentation.
Educational QualificationB.Pharm / M.Pharm / B.Sc / M.Sc (Life Sciences)
Experience2–5 years of experience in Regulatory Affairs.
Hands-on experience in ROW and EU dossier preparation.
Experience in handling variations and renewals.
Key Skills & CompetenciesStrong 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.
Skills Required
- B.Pharm, M.Pharm, B.Sc, or M.Sc in Life Sciences
- 2-5 years of experience in Regulatory Affairs
- Hands-on experience preparing ROW and EU dossiers
- Experience handling regulatory 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
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The Company
What We Do
SAVA Healthcare Limited is an Indian pharmaceutical manufacturer headquartered in Pune, with a registered office in Surendranagar, Gujarat. The company develops and manufactures nasal sprays, drops, dry-powder inhalers, oral solids, and topical preparations. Its business includes international operations, contract manufacturing, companion- and farm-animal healthcare, and herbal products, supported by research, development, and innovation capabilities for domestic and global healthcare markets.
