Director/Senior Director, Regulatory Affairs

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.