Regulatory Affairs Associate at Cosmos Limited

Job Summary

The Regulatory Affairs Associate is responsible for supporting all activities related to product registration in assigned markets. This includes preparing and submitting dossiers for new product registrations, retentions, renewals, variations, and ensuring timely processing of regulatory payments and documentation.

Responsibilities

• Prepare and compile registration dossiers in eCTD format for new registrations, renewals, variations, and retentions in compliance with regulatory guidelines for various export countries.
• Manage timely preparation and submission of regulatory documents, including tender documents and responses to regulatory questionnaires.
• Ensure high accuracy and full compliance in all dossier submissions, with minimal to no errors during review, signing, and approval stages.
• Provide timely and accurate responses to regulatory queries following dossier submissions to support efficient product approvals.
• Proactively apply for and follow up on approvals for new product registrations, variations, renewals, and retentions within the assigned export markets.
• Monitor, process, and track all regulatory payments, ensuring timely clearance and smooth progression of registration processes.
• Maintain proper document control and filing systems to ensure all regulatory documents are accurately recorded, securely stored, and easily retrievable.
• Safeguard all regulatory records to ensure they remain complete, organized, and audit-ready at all times.

Competencies, Qualifications & Experience

Core Competencies

• High attention to detail and commitment to quality standards.
• Excellent verbal and written communication skills.
• Strong organizational abilities with capacity to manage multiple tasks effectively.
• Professionalism, integrity, and adherence to ethical standards.
• Ability to work collaboratively with cross-functional teams.
• Proficiency in MS Office applications (Word, Excel, PowerPoint, Access).

Qualifications

• Minimum of a Diploma in a science-related field.
• Minimum of 1 year of experience in a similar regulatory affairs role.