Executive – Regulatory Affairs (Formulation) Job at SAVA Healthcare
SAVA Healthcare Limited is hiring an Executive / Senior Executive – Regulatory Affairs (Formulation) in Pune. This Executive Job role focuses on preparation and submission of regulatory dossiers for Europe and ROW markets, ensuring compliance with EU, ICH, and country-specific regulatory guidelines while supporting product lifecycle management. Graduates seeking for B pharma jobs or M Pharma jobs can apply now.
Job Details
- Job Title: Executive / Senior Executive – Regulatory Affairs (Formulation)
- Location: Pune, Maharashtra
About the Company
SAVA Healthcare Limited is a pharmaceutical company focused on delivering quality healthcare solutions across regulated and semi-regulated markets. The company emphasizes regulatory compliance, scientific integrity, and global standards to support product approvals and sustainable market presence worldwide. This Executive Job role plays a significant role in the company.
Educational Requirements for Executive Job Role
-
B.Pharm / M.Pharm or equivalent qualification in Pharmaceutical Sciences
Key Responsibilities
- Prepare and compile regulatory dossiers in eCTD format for European submissions
- Demonstrate sound working knowledge of EU DCP/MRP procedures
- Prepare and review regulatory dossiers for ROW markets as per country-specific requirements
- Coordinating with cross-functional teams to compile documentation aligned with ICH and EU guidelines is essential for this Executive Job role
- Prepare and submit variation and renewal applications for approved products
- Respond to regulatory agency queries and deficiencies within defined timelines
- Ensure compliance with current ICH, EU, and national regulatory guidance documents
- Support regulatory strategy planning for new product submissions and lifecycle management
Skills Required for Executive Job Role
- Strong understanding of EU and ICH regulatory requirements
- Hands-on experience with eCTD publishing tools
- Good communication and regulatory documentation skills
- Detail-oriented approach with strong analytical abilities
- Excellent organizational and coordination skills
Why This Job Role?
This Executive Job role offers hands-on exposure to European regulatory submissions and lifecycle management within a structured corporate regulatory environment. It is ideal for professionals looking to strengthen expertise in eCTD publishing, EU procedures, and global regulatory compliance while contributing directly to timely product approvals. Graduates seeking for B pharma jobs or M Pharma jobs can apply now.
