Pharmacology jobs in United States
Director, Regulatory Affairs Opthalmology
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Director, Regulatory Affairs Opthalmology
Job summary
A leading biotech organization is seeking a Director of Regulatory Affairs located in the United Kingdom. The role involves leading global regulatory strategies for ophthalmology products, managing a high-performing regulatory team, and overseeing key regulatory submissions. Candidates should have over 10 years of experience in Regulatory Affairs with a strong background in ophthalmology and proven leadership skills. This role offers a full-time position with a hybrid working model.
Qualifications
- 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.
- Strong experience in authoring and managing global regulatory submissions.
Responsibilities
- Lead the regulatory function and play a central role in shaping and executing global regulatory strategies.
- Define and lead global regulatory strategy for ophthalmology programs.
- Manage, mentor, and develop a team of regulatory professionals.
Skills
Education
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.
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.
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.
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.
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.
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).
Director.
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
Full‑Time
Years
1
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.