Executive

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.