Role Overview

We are seeking a detail-oriented and proactive Export Regulatory Affairs Specialist with mandatory fluency in French and English 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.
• Fluency in French is a must (written and spoken).
• Fluency in English (written and spoken)

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.