Director Regulatory Affairs Freelance

TFS HealthScience is a leading global mid size Contract Research Organization CRO that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities resourcing and Functional Service FSP solutions.

The Regulatory Strategy Consultant Ophthalmology is responsible for providing expert scientific and regulatory guidance on an early phase drug reformulation project including interpretation of preclinical data and defining the optimal regulatory and clinical development strategy in Europe.

As part of our SRS FSP team you will be dedicated to one sponsor a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.

This is contract position at 0.2FTE

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

Bachelors 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

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration quality and making a difference in the lives of patients.

Our core values of Trust Quality Passion Flexibility and Sustainability guide our decisions and shape our culture. By aligning on these values we foster collaboration innovation and a shared commitment to excellence. Together we make a difference.

Our journey began over 30 years ago in Sweden in the city of Lund. As a full service global CRO we build solution driven teams working toward a healthier future. Bringing together over 600 professionals TFS delivers tailored clinical research services in more than 50 countries offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.