Export Regulatory Affairs Specialist

6 days ago


Qesm nd October Al Jizah, Egypt Acdima International Trading Full time 20,000 - 80,000 per year

Job Opportunity: Export Regulatory Affairs Specialist

Are you a regulatory professional with a strong background in the pharmaceutical industry? Join our dynamic team and help us navigate the global regulatory landscape

Key Responsibilities:

Dossier Management: Prepare, review, and submit regulatory dossiers (Regular & CTD) for new product registrations, renewals, and variations across international markets within specific timelines.

Cross-Functional Collaboration: Coordinate with cross-functional teams (e.g., R&D, Quality Assurance, and Quality Control) to ensure product compliance with regulatory requirements.

Technical Review: Review technical documents (e.g., product specifications, stability protocols, analytical methods) to ensure alignment with regulatory expectations.

Query Response: Coordinate the preparation of technical responses to regulatory authority queries and requests for additional information.

Logistics & Follow-up: Handle the sending of samples, legalizations, and hard copies of requested documents via courier and ensure diligent follow-up.

Site Registration: Be responsible for the re-registration of the company and its manufacturing sites.

Candidate Profile & Requirements:

Education: Bachelor's degree in Pharmacy, Veterinary Science, or a related medical field.

Experience: 1 to 3 years of experience in regulatory affairs within the pharmaceutical industry.

Communication: Excellent verbal and written communication skills in both Arabic & English.

Skills: Strong analytical, research, and problem-solving capabilities with a proactive mindset in identifying and addressing export compliance risks across global markets.

Interpersonal Skills: Proven interpersonal and communication abilities.

Attention to Detail: Highly detail-oriented, capable of managing multiple regulatory priorities effectively.

How to Apply:

If you are interested in applying for this vacancy, kindly send your updated resume to:

Crucial Step: The Email Subject Line must be:

"𝗘𝘅𝗽𝗼𝗿𝘁 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 𝗦𝗽𝗲𝗰𝗶𝗮𝗹𝗶𝘀𝘁"

Note: CVs sent without the specific subject line mentioned above will be ignored.

We look forward to receiving your application



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