At a Glance
- Tasks: Provide expert regulatory guidance on early phase drug reformulation projects in ophthalmology.
- Company: Join TFS HealthScience, a leading global mid-sized 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 preferred.
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 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 unique opportunities to work closely with industry-leading pharmaceutical and biotechnology companies, allowing you to make a meaningful impact in the field of ophthalmology. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability not only guide our operations but also create a rewarding environment where your contributions truly matter.
StudySmarter Expert Advice🤫
We think this is how you could land Director Regulatory Affairs - Freelance
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs space, especially those with experience in ophthalmology. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of European regulatory pathways. We want you to shine when discussing how you can guide clinical strategies and engage with authorities effectively.
✨Tip Number 3
Showcase your expertise! During interviews, be ready to discuss specific examples of how you've interpreted preclinical data and linked it to regulatory strategies. This will demonstrate your value to potential employers.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Director Regulatory Affairs - Freelance
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that align with the Director Regulatory Affairs role. Highlight your expertise in ophthalmology and regulatory strategy to catch our eye!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this freelance position. Share your passion for regulatory affairs and how you can contribute to our mission at TFS HealthScience.
Showcase Relevant Experience:When detailing your experience, focus on your background in early phase drug development and interactions with European regulatory authorities. We want to see how your past roles have prepared you for this opportunity!
Apply Through Our Website:We encourage you to apply directly through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss any important updates from us!
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. Understand the latest trends and challenges in early phase drug development, as well as the specific requirements for engaging with European regulatory authorities.
✨Showcase Your Experience
Prepare to discuss your previous experiences in interpreting preclinical data and how you've linked it to clinical strategies. Be ready to provide examples of how you've successfully navigated regulatory pathways in past roles.
✨Ask Insightful Questions
Demonstrate your interest in the role by asking thoughtful questions about the company's current projects and their approach to regulatory strategy. This shows that you're not just interested in the position, but also in how you can contribute to their goals.
✨Align with Their Values
Familiarise yourself with TFS HealthScience's core values: Trust, Quality, Passion, Flexibility, and Sustainability. Think of examples from your career that reflect these values, and be prepared to discuss how you embody them in your work.
