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Regulatory Affairs Specialist

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Regulatory Affairs Specialist

Founded in 2012, EyeD Pharma is a pharmaceutical company dedicated to the development of innovative drug products in ophthalmology. EyeD Pharma is developing innovative products based on a new delivery pathway of well-known drugs with the aim of improving quality of life of patients in various ocular pathologies. In 2019, UniD Manufacturing was born, which brings together production activities.Our headquarter is based in the Science Park of Liège. This collaborative environment allows a positive synergy between RD activities, production, logistics and administration.To support its development, EyeD Pharma is hiring an experienced Regulatoy Affairs Specialist, with strong expertise in regulatory submissions in the United States and a solid background in generic pharmaceutical products.Your Key ResponsibilitiesIn this role, you will be responsible for the preparation, submission, and lifecycle management of regulatory dossiers for our products, particularly for the US market. You will collaborate closely with cross-functional teams to ensure full compliance with FDA and international regulatory requirements.Prepare, submit and manage scientific advice and regulatory dossiers to the FDA and other health authoritiesSupport the maintenance and variation of registered products in the US, including post-approval submissionsMonitor regulatory developments and ensure alignment with evolving FDA, ICH and European requirementsCoordinate cross-functional inputs for high-quality submissionsCommunicate effectively with regulatory agencies and respond to information requests or deficienciesContribute to regulatory strategy for both new submissions and marketed productsEnsure compliance throughout the product lifecycle, from development to post-marketingYour profileCertificate in Regulatory Affairs or degree in Pharmaceutical Sciences, Biochemical and Pharmaceutical Sciences, Biochemistry, or a related field3–5+ years of experience in Regulatory AffairsHands-on experience managing FDA submissions and maintaining registered products in the US. Regulatory lifecycle management, including variations and renewals, and post-approval activitiesExperience with combined product/ medical devices is a strong plusExcellent communication skills and ability to work collaboratively in cross-functional teams Fluency in English, especially for regulatory writing and correspondence with authoritiesProactive, detail-oriented, and capable of working independentlyWilling to work in a start-up environment.Adhere to company’s values: team spirit, caring, integrity, efficiency, empowerment.EyeD Pharma offer A permanent position in an innovative and dynamic and fast growing company;Full time ;Liège. Please send your CV and cover letter in English to : job@eyedpharma.com.

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