At a Glance
- Tasks: Provide expert regulatory guidance on early phase drug reformulation projects in ophthalmology.
- Company: Join TFS HealthScience, a leading global Contract Research Organization.
- Benefits: Flexible contract role with opportunities for personal and professional growth.
- Other info: Collaborative culture focused on trust, quality, and sustainability.
- Why this job: Make a real impact in the lives of patients through innovative drug development.
- Qualifications: Bachelor’s in life sciences; extensive regulatory affairs experience required.
The predicted salary is between 60000 - 80000 £ per year.
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 Provider (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 a contract position at 0.2FTE.
Responsibilities
- 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
Qualifications
- 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
What We Offer
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.
About Us
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.
Director Regulatory Affairs - Freelance in London employer: TFS HealthScience
TFS HealthScience is an exceptional employer that prioritises personal and professional growth within a collaborative and innovative work culture. As a mid-sized Contract Research Organization, we offer our employees the opportunity to work closely with industry leaders in biotechnology and pharmaceuticals, while being guided by our core values of Trust, Quality, Passion, Flexibility, and Sustainability. Joining our team means making a meaningful impact on patients' lives and contributing to a healthier future in a supportive environment.
StudySmarter Expert Advice🤫
We think this is how you could land Director Regulatory Affairs - Freelance in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in regulatory affairs or have ties to TFS HealthScience. A friendly chat can open doors and give you insights that might just land you that freelance gig.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of European regulatory pathways. We want to see you shine when discussing your experience with preclinical data and clinical strategies. Show us you know your stuff!
✨Tip Number 3
Don’t forget to showcase your passion for ophthalmology! Whether it’s through your previous projects or personal interests, let us see how dedicated you are to making a difference in this field.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect with us directly.
We think you need these skills to ace Director Regulatory Affairs - Freelance in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in regulatory affairs and ophthalmology. We want to see how your background aligns with the specific requirements of the role, so don’t be shy about showcasing relevant projects!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role and how your expertise can contribute to our mission. Keep it concise but impactful – we love a good story!
Showcase Your Regulatory Knowledge:Since this role involves navigating European regulatory pathways, make sure to highlight any experience you have with regulatory authorities. We’re looking for someone who can hit the ground running, so let us know what you’ve done!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team!
How to prepare for a job interview at TFS HealthScience
✨Know Your Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially in ophthalmology. Be ready to discuss how you've interpreted preclinical data in the past and how it influenced your regulatory strategies.
✨Showcase Your Experience
Prepare specific examples from your previous roles where you successfully engaged with European regulatory authorities. Highlight any scientific advice procedures you've navigated and how they shaped your development recommendations.
✨Understand the Company Culture
Familiarise yourself with TFS HealthScience's core values: Trust, Quality, Passion, Flexibility, and Sustainability. Think about how your personal values align with theirs and be ready to share examples that demonstrate this alignment during the interview.
✨Ask Insightful Questions
Prepare thoughtful questions about the role and the company. Inquire about their current projects in ophthalmology or how they approach regulatory challenges. This shows your genuine interest and helps you assess if it's the right fit for you.
