Acdima International Trading

Export Regulatory Affairs Specialist

Posted: 6 days ago

Job Description

๐Ÿš€ Job Opportunity: Export Regulatory Affairs Specialist ๐Ÿš€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!๐Ÿ“ 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.๐ŸŽฏ Candidate Profile & Requirements:Education: Bachelorโ€™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.๐Ÿ“ง How to Apply:If you are interested in applying for this vacancy, kindly send your updated resume to: export@acdimatrading.comCrucial Step: The Email Subject Line must be:"๐—˜๐˜…๐—ฝ๐—ผ๐—ฟ๐˜ ๐—ฅ๐—ฒ๐—ด๐˜‚๐—น๐—ฎ๐˜๐—ผ๐—ฟ๐˜† ๐—”๐—ณ๐—ณ๐—ฎ๐—ถ๐—ฟ๐˜€ ๐—ฆ๐—ฝ๐—ฒ๐—ฐ๐—ถ๐—ฎ๐—น๐—ถ๐˜€๐˜"โš  Note: CVs sent without the specific subject line mentioned above will be ignored.We look forward to receiving your application!

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