Director/Senior Director, Regulatory Affairs

Tenpoint Therapeutics, Ltd.

3d•$230,000 - $300,000•Hybrid

About The Position

This 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.

Requirements

Bachelor’s degree or equivalent number of years industry work experience is required.
10+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry.
Proven experience with NDAs in the US.
Strong expertise in small molecules.
Deep understanding of US regulatory requirements.
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.
Proficiency with MS Office applications, especially Excel, Word, and PowerPoint.

Nice To Haves

Advanced degree (MS, PhD, PharmD) preferred.
Ophthalmology experience is strongly preferred.
DMF and pharmacovigilance experience is a plus.
Biologics experience is preferred but not required.
Familiarity with global regulatory frameworks (EMA, PMDA, etc.) is also preferred.
Veeva RIM would be considered a plus.

Responsibilities

Lead regulatory strategy and execution for YUVEZZI™ including all NDA support and ongoing regulatory filings.
Manage regulatory submissions, including NDAs, DMFs, PAIs, and ongoing regulatory filings 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.