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- Tasks: Lead regulatory strategies for ophthalmology programs and manage submissions to health authorities.
- Company: Dynamic biotech firm focused on innovative ophthalmology solutions.
- Benefits: Competitive salary, hybrid work model, and opportunities for professional growth.
- Why this job: Shape the future of ophthalmology while leading a passionate team in a fast-paced environment.
- Qualifications: Advanced degree in life sciences and 10 years of regulatory affairs experience required.
- Other info: Join a collaborative culture in Geneva or Lausanne with excellent career advancement potential.
The predicted salary is between 72000 - 108000 ÂŁ per year.
The Director of Regulatory Affairs will lead the regulatory function and play a central role in shaping and executing global regulatory strategies for our ophthalmology assets.
Key Responsibilities
- Regulatory Leadership & Strategy: Define and lead global regulatory strategy for ophthalmology programs from Phase II through Phase III and registration. Serve as the primary regulatory contact with EMA, FDA, Swissmedic and other health authorities. Develop and maintain regulatory roadmaps aligning cross‑functional teams on timelines and deliverables.
- Execution & Submissions: Oversee the preparation, review, and submission of key regulatory documents (INDs / CTAs, Scientific Advice, Briefing Books, PIPs, Orphan Designation, BLA / NDA / MAA modules). Ensure timely responses to health authority queries and manage interactions / meetings with agencies. Lead regulatory risk assessments and provide mitigation strategies throughout the product lifecycle.
- Team Leadership: Manage, mentor, and develop a team of regulatory professionals. Build scalable regulatory capabilities suitable for a growing biotech organization. Foster a collaborative, accountable, and solution‑oriented culture.
- Cross‑functional Collaboration: Partner with Clinical, CMC, Nonclinical, and Quality teams to ensure regulatory alignment across all development activities. Provide regulatory input into study protocols, development plans, and labeling strategies. Support due diligence activities and business development opportunities as needed.
Qualifications & Experience
- Advanced degree in life sciences, pharmacy or related field; higher degree (PhD, PharmD, MSc) preferred.
- 10 years experience in Regulatory Affairs with significant exposure to ophthalmology or related therapeutic areas.
- Proven track record of leading regulatory strategy and interactions with EMA and FDA particularly from Phase II through pivotal Phase III and registration.
- Strong experience in authoring and managing global regulatory submissions (IND / CTA / MAA, NDA / BLA).
- Prior leadership / line management experience – able to motivate and develop a high‑performing regulatory team.
- Experience in small to mid‑sized biotech or pharma environment with hands‑on strategic and operational responsibilities.
- Excellent knowledge of ICH, EU, US and Swiss regulatory requirements.
- Strong communication, influencing and leadership skills with ability to work in a fast‑paced entrepreneurial setting.
- Based in Geneva or Lausanne area with a hybrid working model (on‑site 23 days / week).
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
Employment Type: Full‑Time
Experience Years: 1
Director, Regulatory Affairs Opthalmology in Horley employer: Barrington James
Contact Detail:
Barrington James Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Regulatory Affairs Opthalmology in Horley
✨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 EMA and FDA regulations. Be ready to discuss your past experiences leading regulatory strategies and how you’ve tackled challenges in submissions.
✨Tip Number 3
Showcase your leadership skills! Be prepared to share examples of how you've managed and developed teams in previous roles. Highlighting your ability to foster a collaborative culture will set you apart.
✨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 Opthalmology in Horley
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in regulatory affairs, especially in ophthalmology. We want to see how your background aligns with the specific requirements of the role.
Showcase Your Leadership Skills: Since this is a director position, it's crucial to demonstrate your leadership experience. Share examples of how you've managed teams and led regulatory strategies in your previous roles. We love seeing strong leaders!
Be Clear and Concise: When writing your application, keep it clear and to the point. Use bullet points where possible to make it easy for us to read. We appreciate straightforward communication, especially in regulatory affairs.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at Barrington James
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations from EMA, FDA, and Swissmedic. Familiarise yourself with the specific requirements for ophthalmology assets, especially around Phase II and III submissions. This will show that you're not just knowledgeable but also genuinely interested in the role.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in the past. Think about times when you mentored others or built regulatory capabilities in a growing organisation. Highlighting your leadership experience will demonstrate that you can manage and develop a high-performing team.
✨Be Ready for Cross-Functional Collaboration
Expect questions about how you’ve worked with Clinical, CMC, and Quality teams in the past. Have specific examples ready that illustrate your ability to align regulatory strategies with cross-functional goals. This will show that you understand the importance of collaboration in achieving regulatory success.
✨Prepare for Regulatory Risk Assessments
Think about how you've handled regulatory risks in previous roles. Be prepared to discuss your approach to risk assessment and mitigation strategies throughout the product lifecycle. This will highlight your strategic thinking and problem-solving skills, which are crucial for this position.
