Regulatory Affairs Associate at Cosmos Limited

Job Summary

• Responsible for supporting all activities related to registration of products in the assigned, including dossier preparations for new products, retentions, renewals, variations, timely payments etc.

Responsibilities

• Prepare and compile registration dossiers in eCTD format for new product registrations, renewals, variations, and retentions in compliance with the regulatory guidelines of various export countries
• question preparation and submersion of regulatory documentation, including tender documents and responses to regulatory
• Ensure high accuracy and compliance indossier submissions, with minimal to no nors during the approval and signing processes Provide timely and accurate responses to regulatory queries following product dossier submissions to facilitate efficient product approvals Proactively apply for and follow up on approvals for new product registrations, product variations, retentions, and renewals in assigned export countries
• Monitor and process timely regulatory payments, ensuring smooth progression of the registration process
• Maintain proper document control and filing systems, ensuring all documents are accurately recorded, securely stored, and readily retrievable
• Ensure no documentation is lost and all regulatory records are maintained in a safe, organized, and audit ready manner

Competencies. Qualifications & Experience

• Attention to detail and an affinity for high standards.
• Excellent verbal, written, organizational skills
• Strong written and verbal communication skills
• Highly organized, detail oriented and ability to mak
• Integrity, ethical and professional approach to work
• Ability to work along with other departments
• Computer Literacy Le. Ms. Word, Excel, PowerPoint, Access etc.
• Minimum of a Diploma in any science related field.
• Minimum of 1 year experience in a similar role.