Regulatory Affairs Specialist - Egypt
Join EVA Pharma: A Global Leader in Healthcare Innovation!
At EVA Pharma, we are committed to making health and well-being accessible to all. As a global healthcare company, we leverage innovation to address unmet medical needs. Our diverse portfolio includes branded generics, vaccines, OTC products, food supplements, herbal medicines, and veterinary products. With a presence in over 40 countries and as one of the fastest-growing pharmaceutical manufacturers in the MENA region, EVA Pharma is at the forefront of healthcare transformation. EVA Pharma is looking to have a “Regulatory Affairs Specialist” to join EVA Pharma Regulatory Affairs Team and be responsible for all Regulatory activities for Egypt cluster.
Key Responsibilities:
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Regulatory Compliance: Ensure all pharmaceutical products comply with local (Egyptian Drug Authority - EDA) and international regulations and standards and be the primary point of contact,
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Product Registration: Prepare, compile, and submit dossiers for new drug approvals, renewals, and variations. Manage the entire registration process until product approval.
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Compliance Monitoring: Continuously monitor changes in laws, regulations, and guidelines in Egypt and ensure the company remains compliant. Advise internal teams of relevant changes.
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Labeling and Packaging Review: Review and approve pharmaceutical labeling, packaging, and promotional materials to ensure compliance with regulatory requirements.
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Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, Manufacturing, and Marketing teams to ensure that regulatory requirements are integrated into all stages of product development.
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Risk Assessment: Evaluate potential regulatory risks and develop strategies to mitigate them, ensuring minimal delays in approvals or compliance issues.
Job Score Card
Qualifications
Bachelor’s degree in Pharmacy. 0-2 years of experience in the same field. CTD experience is a plus (regardless of the years of experience) Excellent communication skills
Job Location Giza, Egypt Job Role Other Years of Experience Min: 0 Max: 3 Residence Location Egypt
Job Role: Other
Experience: 2 - 3 Years of Experience
Job Role: Other
Experience: 0 - 2 Years of Experience
