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 and 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 and 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 and 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)

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