Director, Regulatory Affairs Opthalmology
Director, Regulatory Affairs Opthalmology
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Job Description
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
Employment Type
Full-Time
