We are looking for Lead - Regulatory Affairs (RoW - Regulated & Emerging Markets)for our Vaccine Plant.

Role Purpose

Drive end-to-end regulatory strategy and execution for vaccine registrations across Rest of World (RoW) markets. Lead submissions, approvals, lifecycle management, and regulatory compliance to ensure timely market access and business growth.

Key Responsibilities

Lead preparation, review, and submission of CTD/eCTD dossiers for RoW markets.

Develop and execute regulatory strategies for recent registrations and market expansion.

Manage regulatory submissions via Health Authority portals and secure timely Dossier & GMP approvals.

Lead post-approval lifecycle activities including variations, renewals, and change controls.

Coordinate and prepare responses to Health Authority queries in collaboration with cross-functional teams.

Assess regulatory impact of product/manufacturing changes and drive implementation strategies.

Maintain regulatory databases, approval trackers, and document repositories.

Prepare technical documentation for tenders, customer requests, and regulatory submissions.





Coordinate with QA and cross-functional teams for Master File updates, registration samples, and regulatory documentation.

Review and approve labels, pack profiles, package inserts, and artworks for regulatory compliance.

Support Health Authority and customer audits for assigned markets.

Mentor team members and drive compliance with Regulatory Affairs SOPs and global requirements.

Experience

10-16 years of Regulatory Affairs experience in the vaccine manufacturing industry with strong exposure to RoW regulated and emerging markets, regulatory submissions, and lifecycle management.

Key Competencies

CTD/eCTD Dossier Preparation & Submissions

RoW Regulatory Strategy & Compliance

Lifecycle Management & Change Control

Health Authority Interactions

Labeling & Artwork Review

Cross-functional Stakeholder Management

Project Planning & Execution

Strong Communication & Leadership Skills

Interested candidates can share profiles via email to [email protected] with Subject Line "Application for RA - Lead Role"

📌 Regulatory Affairs Lead - RoW -Emerging & Regulated Markets -Biologics (Telangana)
🏢 Biological E
📍 Telangana