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
- 35 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.
