Position SummaryThis position will lead the regulatory strategy and execution for YUVEZZI™ in the US, Canada, LatAm, Asia and MENA overseeing all aspects of regulatory submissions, compliance, and health authority interactions. This role collaborates cross-functionally to support product development, approval, and lifecycle management, ensuring alignment with global regulatory standards and business objectives.
Key Responsibilities• Lead regulatory strategy and execution for YUVEZZI™ including all NDA support and ongoing regulatory filings.
• Manage regulatory submissions, including NDAs, DMFs, PAIs, and annual commitments for YUVEZZI™.
• Develop and implement regulatory strategies to support product development, approvals, and lifecycle management.
• Prepare and review regulatory documents (INDs, NDAs, DMFs, annual reports, amendments, responses to agency queries).
• Lead interactions with FDA and global health authorities and partners including regulatory meetings, negotiations, and responses to inquiries.
• Ensure regulatory compliance with FDA, ICH, EMA, and other global regulations.
• Collaborate cross-functionally with clinical, CMC, non-clinical, and commercial teams to align regulatory strategy with business objectives.
• Monitor evolving regulatory requirements and provide guidance to internal teams on potential impacts to development programs.
• Represent Regulatory Affairs in strategic discussions, influencing key decisions for clinical development and commercialization as well as with licensing partners in regard to regulatory activities.
• Participation as a member of the PRC committee to review commercial advertising and other similar documents
Qualifications• Bachelor's degree or equivalent number of years industry work experience is required; Advanced degree (MS, PhD, PharmD) preferred.
• 10+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry; ophthalmology experience is strongly preferred.
• Proven experience with NDAs in the US (DMF and pharmacovigilance experience is a plus).
• Strong expertise in small molecules; biologics experience is preferred but not required.
• Deep understanding of US regulatory requirements; familiarity with global regulatory frameworks (EMA, PMDA, etc.) is also preferred.
• Experience leading regulatory interactions with the FDA and other global health authorities specifically Canada, LatAm, AsiaPac and MENA.
• Demonstrated ability to develop and execute regulatory strategies from early development through commercialization.
• Strong knowledge of CMC regulatory requirements for small molecules and biologics.
• Excellent project management skills, with the ability to prioritize tasks in a fast-paced environment.
• Experience in a PRC committee process
• Experience with a regulatory information management system. Veeva RIM would be considered a plus.
• Proficiency with MS Office applications, especially Excel, Word, and PowerPoint.
Physical Requirements & ADA Statement This role is primarily a desk-based job requiring the ability to operate a computer and communicate effectively in a clinical work environment. The employee may be required to sit for extended periods, engage in video or phone meetings, and use standard office equipment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.
Salary and Benefits InformationWe know our people are the driving force behind the success of our mission and vision. That's why we offer a competitive benefit package to attract the very best talent to our team and to take care of our employees and their families. Below is a snapshot of our U.S. benefits package for full-time employees.
- Generous medical, dental, and vision health insurance plans
- Flexible spending accounts for health and dependent care
- Short-term, long-term, and life/AD&D insurance
- Employee Assistance Program
- 20 paid vacation days, 12 paid holidays, and 12 sick days
- 401(k) Retirement Plan with 100% company match up to 4% and immediate vesting
CompensationThe base salary range for the Director/Senior Director, Regulatory Affairs is $230,000-$300,000 USD annually. Final pay determinations will depend on various factors, including but not limited to experience level, knowledge, skills, and abilities.
