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 R&D 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 Responsibilities

In 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 authorities
• Support the maintenance and variation of registered products in the US, including post-approval submissions
• Monitor regulatory developments and ensure alignment with evolving FDA, ICH and European requirements
• Coordinate cross-functional inputs for high-quality submissions
• Communicate effectively with regulatory agencies and respond to information requests or deficiencies
• Contribute to regulatory strategy for both new submissions and marketed products
• Ensure compliance throughout the product lifecycle, from development to post-marketing

Your profile

• Certificate in Regulatory Affairs or degree in Pharmaceutical Sciences, Biochemical and Pharmaceutical Sciences, Biochemistry, or a related field
• 3–5+ years of experience in Regulatory Affairs
• Hands-on experience managing FDA submissions and maintaining registered products in the US. Regulatory lifecycle management, including variations and renewals, and post-approval activities
• Experience with combined product/ medical devices is a strong plus
• Excellent communication skills and ability to work collaboratively in cross-functional teams
• Fluency in English, especially for regulatory writing and correspondence with authorities
• Proactive, detail-oriented, and capable of working independently
• Willing 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.