Regulatory Affairs Associate

Role Overview

The Regulatory Affairs Associate keeps product registrations moving across assigned export markets by preparing, submitting, and maintaining the documentation regulators require. This role sits at the center of registration timelines, payment tracking, and query responses, helping the business secure and retain market access without unnecessary delays. Success depends on precision, follow-through, and clear coordination with internal teams and external regulatory contacts.

Key Responsibilities

• Build and assemble electronic common technical document (eCTD) submissions for new product registrations, renewals, variations, and retention filings, adapting each package to the requirements of the destination market.
• Prepare and send regulatory submissions and tender-related documents on schedule, including responses to questionnaires received from regulatory agencies.
• Check dossier content before internal review and sign-off to catch inconsistencies, missing information, or formatting issues that could trigger questions or delays.
• Answer regulatory follow-up queries accurately and promptly after submissions, tracking each exchange until the agency confirms receipt or requests no further action.
• Drive registration approvals forward by monitoring application status and following up on new registrations, variations, renewals, and retentions in assigned export countries.
• Log, process, and reconcile regulatory fees and other payments, confirming that each transaction clears in time to keep registration steps on track.
• Maintain a controlled filing system for regulatory records so documents can be located quickly, remain version-controlled, and stay complete for audits.
• Support cross-functional requests for registration documentation and keep internal partners informed of submission milestones, pending items, and approval outcomes.

Requirements & Qualifications

• A diploma in a science-related discipline is the minimum educational requirement.
• At least one year of hands-on experience in a regulatory affairs role or a closely related registration support position.
• Familiarity with eCTD submission formats and the regulatory registration processes used in export markets.
• Strong attention to detail and a track record of preparing submission-ready documents with minimal errors through review, signing, and approval stages.
• Clear written and verbal communication skills for responding to regulatory queries and coordinating with colleagues across teams.
• Solid organisational skills, with the ability to manage several dossiers, deadlines, and payment tasks at once.
• Professional judgement, integrity, and comfort working within ethical and compliance-driven processes.
• Proficiency in Microsoft Office tools, including Word, Excel, PowerPoint, and Access.