Director, Regulatory Affairs Opthalmology

Job Description

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).

Required Experience

Director.

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

Vacancy

1