Director, Regulatory Affairs Opthalmology

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 2-3 days/week)