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.

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.

Director – Regulatory Affairs

Key skills