Executive / Senior Executive – Regulatory Affairs (Formulation)
Company: SAVA Healthcare Limited
Location: Pune
Department: Regulatory Affairs
Job Purpose
The role focuses on preparing, compiling, and submitting regulatory dossiers in compliance with international guidelines, primarily for:
Europe (eCTD format)
Rest of the World (ROW) markets
The position supports timely regulatory approvals and lifecycle management of pharmaceutical products.
Key Responsibilities
Regulatory Dossier Preparation
Prepare and compile dossiers in eCTD format for European submissions
Handle regulatory submissions for ROW markets based on country-specific requirements
Regulatory Procedures & Compliance
Work on EU DCP/MRP procedures
Ensure compliance with:
ICH guidelines
EU regulatory guidelines
National regulatory requirements
Cross-Functional Coordination
Coordinate with internal departments to gather and compile regulatory documentation
Lifecycle Management
Prepare and submit:
Variation applications
Renewal packages for approved products
Regulatory Query Management
Respond to agency queries and deficiency letters within defined timelines
Regulatory Strategy Support
Assist in:
New product submission strategies
Product lifecycle management activities
Desired Candidate Profile
Educational Qualification
B.Pharm / M.Pharm
Equivalent degree in Pharmaceutical Sciences
Experience
2–5 years of experience in Regulatory Affairs (Formulation)
Hands-on experience with European eCTD submissions is mandatory
Required Skills
Regulatory Knowledge
Strong understanding of:
EU regulatory requirements
ICH guidelines
DCP/MRP procedures
Technical Skills
Proficiency in eCTD publishing tools
Communication & Documentation
Good written and verbal communication skills
Strong documentation abilities
Personal Skills
Detail-oriented approach
Strong analytical thinking
Good organizational and time management skills
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
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