Director – Regulatory Affairs

Tenpoint Therapeutics, Ltd.

Director of Regulatory Affairs at Tenpoint Therapeutics leading strategy and compliance for YUVEZZI™. Overseeing regulatory submissions and cross-functional collaboration across multiple regions.

Posted 7/11/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $230,000 - $300,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

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
Hybrid work options
Wellness Resources
Stock Options

ATS Keywords

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Hard Skills & Tools

Regulatory SubmissionsNDADMFINDRegulatory ComplianceCMC Regulatory RequirementsPharmacovigilanceSmall MoleculesBiologicsRegulatory Strategy Execution

Soft Skills

CollaborationInfluencingPrioritizationCommunicationNegotiation