Export Regulatory Affairs Specialist

2 weeks ago

Cairo, Egypt Jamjoom Pharma Full time

**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.
- **Problem Solving**: Proactive in identifying issues and driving timely regulatory solutions.
- **Integrity & Compliance**: Demonstrates strong ethical standards and commitment to regulatory compliance.

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