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.
