Job Title: Executive / Senior Executive – Regulatory Affairs (Formulation)
Location: Pune, Maharashtra
Department: Regulatory Affairs
Company: SAVA Healthcare Limited
Job Purpose:
To manage the preparation, compilation, and submission of regulatory dossiers in compliance with international guidelines, with a focus on Europe (eCTD format) and Rest of the World (ROW) markets. The role ensures timely approvals and lifecycle management of pharmaceutical products.
Key Responsibilities:
Preparation and compilation of dossiers in eCTD format for European submissions (hands-on experience in eCTD is a must).
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 queries and deficiencies raised by regulatory agencies within stipulated timelines.
Ensure compliance with current ICH, EU, and national regulatory guidance documents.
Support in regulatory strategy planning for new product submissions and lifecycle management.
Desired Candidate Profile:
Qualification: B.Pharm / M.Pharm or equivalent in Pharmaceutical Sciences.
Experience: 2–5 years of relevant experience in Regulatory Affairs (formulation) with hands-on experience in eCTD submissions for Europe.
Skills Required:
- Strong understanding of EU and ICH regulatory requirements.
- Proficiency in eCTD publishing tools.
- Good communication and documentation skills.
- Detail-oriented with strong analytical and organizational abilities.
