Export Regulatory Affairs Specialist

Role Overview

We are seeking a detail-oriented and proactive Export Regulatory Affairs Specialist to support global regulatory compliance and international market access. This role is critical in managing export regulatory submissions, ensuring adherence to country-specific requirements, and coordinating cross-functionally to facilitate timely and compliant product exports.

Key Responsibilities

• Compile, format, and submit dossiers in CTD/eCTD format, ensuring accuracy, consistency, and compliance with international standards.
• Manage Certificates of Pharmaceutical Product (CPP) issuance and legalization processes.
• Ensure compliance with export regulations, customs requirements, and country-specific guidelines.
• Liaise with agents, distributors, and internal teams to resolve regulatory queries.
• Maintain up-to-date knowledge of global regulatory frameworks and changes impacting exports.
• Support audits, inspections from export countries.
• Develop and optimize workflows for regulatory submissions and export documentation.

Qualifications & Requirements

Education

• Bachelor’s degree in pharmacy, Life Sciences, or a related field (mandatory).
• Additional training or certification in Regulatory Affairs is considered a plus.

Experience

• 3–5 years of hands-on experience in Regulatory Affairs within the pharmaceutical industry, with a strong focus on export submissions.
• Proven experience in CTD/eCTD dossier preparation, publishing, and submission for international markets.
• Solid knowledge of international regulatory requirements and export-related guidelines.
• Experience working with agents and distributors across multiple countries is an advantage.

Skills & Competencies

• Regulatory Expertise: Strong understanding of global regulatory frameworks and export compliance requirements.
• Technical Writing: Excellent ability to prepare clear, accurate, and compliant regulatory documentation.
• Communication: Fluent in English (written and spoken); French language skills are required.
• Organization & Attention to Detail: High level of accuracy in managing multiple dossiers and regulatory documents.
• Cross-functional Collaboration: Ability to work effectively with internal teams and external partners.
• Systems & Tools: Proficient in documentation management systems and MS Office applications.
• Problem Solving: Proactive in identifying issues and driving timely regulatory solutions.
• Integrity & Compliance: Demonstrates strong ethical standards and commitment to regulatory compliance.