Regulatory Affairs Executive

Job description

Hi...

Role Overview

As a Regulatory Affairs Executive, you will support regulatory submissions, compliance, and product registrations for domestic and international markets. You will play a vital role in dossier compilation, coordinating with authorities, and ensuring timely approvals.

Key Responsibilities

 Assist in dossier preparation and submission (CTD, ACTD, eCTD formats).  Coordinate with regulatory agencies and health authorities for approvals.  Support bioequivalence study documentation and compliance.  Manage renewals, variations, and post-approval regulatory updates.  Assist in preparation of parenteral dossiers (added advantage).  Maintain accurate and updated regulatory documentation.  Collaborate with internal teams and international clients.

Skills & Experience

 1+ year of experience in Regulatory Affairs within the pharmaceutical industry.  In-depth knowledge of CTD, ACTD, eCTD dossier compilation, and regulatory submission processes.  Experience in handling bioequivalence studies and related regulatory documentation.  Experience in preparing parenteral dossiers will be an added advantage.  Strong understanding of global regulatory requirements and product lifecycle management.  Expertise in coordinating with regulatory agencies, health authorities, and international clients.  Excellent communication, leadership, and problem-solving skills.  Proficiency in MS Office (Word, Excel, PowerPoint) for documentation and reporting.

Why You’ll Love It Here

 Career growth opportunities in regulatory affairs.  Exposure to international markets and regulatory submissions.  Collaborative work environment with innovation-driven culture.

Interested candidates can send you CV on reshail.paulwhiteforce@gmail.com