Executive / Senior Executive – Regulatory Affairs Job At SAVA Healthcare Limited
The Executive / Senior Executive – Regulatory Affairs (Formulation) role in Pune at SAVA Healthcare Limited is ideal for regulatory professionals with hands-on experience in eCTD submissions. This Executive Job position focuses on European and ROW regulatory dossiers, lifecycle management, and compliance with ICH and EU guidelines. Graduates seeking 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 committed to regulatory excellence and global compliance. The organization focuses on delivering high-quality pharmaceutical products while meeting international regulatory standards across European and ROW markets.
Educational Requirements for an Executive Job
-
B. Pharm / M. Pharm or equivalent qualification in Pharmaceutical Sciences
Key Responsibilities for an Executive Job
- Preparation and compilation of regulatory dossiers in eCTD format for European submissions
- Sound understanding and working knowledge of EU DCP/MRP procedures
- Preparation and review of regulatory dossiers for ROW markets as per country-specific requirements
- Coordination with cross-functional teams to compile regulatory documentation in line with ICH and EU guidelines
- Preparation and submission of variation and renewal packages for approved products
- Responding to regulatory agency queries and deficiencies within stipulated timelines
- Ensuring compliance with current ICH, EU, and national regulatory guidance documents
- Supporting regulatory strategy planning for new product submissions and lifecycle management
Skills Required for an Executive Job
- Strong understanding of EU and ICH regulatory requirements
- Hands-on experience with eCTD submissions and eCTD publishing tools
- Good communication and documentation skills
- Detail-oriented approach with strong analytical and organizational abilities
- Relevant experience of 2–5 years in Regulatory Affairs (Formulation)
Why This Job Role?
This Executive Job role offers direct exposure to European regulatory submissions, lifecycle management, and strategic regulatory planning, making it an excellent opportunity for professionals aiming to grow in global Regulatory Affairs within a reputed pharmaceutical organization. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
