Regulatory Affairs Executive

We are looking for an experienced Regulatory Affairs to manage and oversee regulatory submissions and compliance for Emerging or ROW (Rest of the World) markets. The role requires in-depth knowledge of international registration requirements, dossier preparation, and life-cycle management of pharmaceutical products.

Key Responsibilities

Manage regulatory submissions, approvals, and renewals for Emerging & ROW markets (Asia, Africa, Latin America, CIS, Middle East, etc.).

Prepare, review, and compile CTD / ACTD dossiers for new product registrations.

Coordinate with R&D, QA, QC, and Production teams to gather technical data and ensure dossier readiness.

Maintain and update the registration database and product life-cycle documentation.

Handle query responses and communicate with overseas partners, distributors, and regulatory agencies.

Ensure timely renewal, variation filing, and post-approval changes as per local market requirements.

Keep track of country-specific regulatory guidelines and updates for compliance.

Support regulatory audits and inspections as needed.

Provide regulatory input during new product development and launch planning.

Desired Candidate Profile

Graduate / Post-Graduate in Pharmacy or Life Sciences.

3 to 10 years of experience in Regulatory Affairs within a pharmaceutical formulation company.

Hands-on experience in dossier compilation and submission for Emerging & ROW markets.

Strong understanding of CTD/ACTD and ECTD formats, stability data, and technical documentation.

Excellent communication, coordination, and documentation skills.

Experience with export markets and regulatory communication preferred

Location - Malad - Mumbai

Salary range - 3 to 8 lacs

Interested candidate please mail me your cv at hr@archerchem.commor what's app at 9028871352.