Regulatory Affairs - Head - ROW

We're Hiring | AVP – Regulatory Affairs (ROW) | Formulation at Dholka Location

Department: Regulatory Affairs – Formulation

Industry: Pharmaceutical

Qualification: M. Pharma / M.Sc

Experience Required: 16+ Years

CTC: Up to 80 LPA

We are looking for an experienced and dynamic professional for the position of AVP – Regulatory Affairs (ROW + Domestic) in the Formulation segment.

Key Responsibilities:

* Regulatory strategy and dossier management for ROW & Domestic markets

* Compilation, review, and submission of regulatory filings

* Coordination with cross-functional teams for timely approvals

* Handling regulatory queries, deficiencies, and lifecycle management

* Ensuring compliance with applicable regulatory guidelines and standards

Desired Profile:

️ Strong exposure to formulation regulatory affairs

️ Hands-on experience in ROW and Domestic market submissions

️ Leadership and stakeholder management skills

️ Excellent knowledge of regulatory guidelines and documentation