Director, Regulatory Affairs

TFS HealthScience - Contract Research Organization

Regulatory Strategy Consultant providing expert regulatory guidance on ophthalmology drug reformulation. Engaging European authorities and defining clinical development strategy for a leading global pharmaceutical company.

Posted 5/25/2026contractRemote • 🇬🇧 United KingdomLeadWebsite

About the role

Key responsibilities & impact

Provide scientific interpretation of preclinical ophthalmology data including in vivo models to assess proof of concept
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 pathway
Support planning and execution of interactions with European regulatory authorities including scientific advice
Recommend appropriate regulatory pathways and authority engagement strategies within Europe

Requirements

What you’ll need

Bachelor’s degree in life sciences or equivalent, advanced degree preferred
Extensive experience in regulatory affairs with a focus on early phase strategy
Strong background in ophthalmology drug development
Proven experience interpreting preclinical data and linking it to clinical and regulatory strategy
Experience engaging with European regulatory authorities including scientific advice procedures

Benefits

Comp & perks

Opportunities for personal and professional growth in a rewarding environment
Team values collaboration, quality, and making a difference in the lives of patients
Core values of Trust, Quality, Passion, Flexibility, and Sustainability

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory affairsophthalmology drug developmentpreclinical data interpretationclinical strategystudy designdevelopment pathwayregulatory pathwaysauthority engagement strategies

Soft Skills

scientific interpretationadvisory skillsplanningexecution

Certifications

Bachelor’s degree in life sciencesadvanced degree preferred