Job Description

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.