Regulatory affairs Specialist At EVA Pharma
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:
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,
Product Registration:
Prepare, compile, and submit dossiers for new drug approvals, renewals, and variations. Manage the entire registration process until product approval.
Compliance Monitoring:
Continuously monitor changes in laws, regulations, and guidelines in Egypt and ensure the company remains compliant. Advise internal teams of relevant changes.
Labeling and Packaging Review:
Review and approve pharmaceutical labeling, packaging, and promotional materials to ensure compliance with regulatory requirements.
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.
Risk Assessment:
Evaluate potential regulatory risks and develop strategies to mitigate them, ensuring minimal delays in approvals or compliance issues.
Qualifications:
Bachelor’s degree in Pharmaceutical Sciences.
0-2 years of experience in Regulatory Affairs.
Knowledge of any of the following: Azure, MongoDB, Magento or Angular 2 is a plus.
Very good in English, both verbal and written.