jamjoompharma/careers
Export Regulatory Affairs Specialist
jamjoompharma/careers, Egypt, Pennsylvania, United States
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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr