Director of Regulatory Affairs

Job summary

This role involves providing expert scientific and regulatory guidance for an early phase drug reformulation project in ophthalmology, focusing on the interpretation of preclinical data and the development of regulatory and clinical strategies in Europe.

Qualifications

• Bachelor’s degree in life sciences or equivalent; advanced degree preferred
• Extensive experience in regulatory affairs, particularly in early phase strategy
• Strong background in ophthalmology drug development
• Proven ability to interpret preclinical data and connect it to clinical and regulatory strategies
• Experience with European regulatory authorities, including scientific advice procedures

Responsibilities

What We Offer

Opportunities for personal and professional growth in a collaborative and quality-focused environment, guided by core values of Trust, Quality, Passion, Flexibility, and Sustainability.

• Provide scientific interpretation of preclinical ophthalmology data, including in vivo models for proof of concept assessment
• Translate nonclinical findings into regulatory and early clinical development recommendations
• Define and guide the overall regulatory and clinical strategy for the program
• Advise on optimal next steps in development, including study design and development pathways
• Support planning and execution of interactions with European regulatory authorities, including scientific advice
• Recommend appropriate regulatory pathways and authority engagement strategies within Europe