Director – Regulatory Affairs

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Tenpoint Therapeutics, Ltd.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

💰 $20M Debt financing on 2021-09

Biotechnology • Pharmaceuticals

Tenpoint Therapeutics, Ltd. is a clinical-stage ophthalmology company developing pharmacological treatments to rejuvenate near vision and address age-related eye conditions. The company focuses on presbyopia and is advancing a pipeline that also targets cataracts and geographic atrophy, partnering with eye care professionals and pursuing regulatory approvals (e. g. , an FDA NDA acceptance for BRIMOCHOL™ PF). Headquartered in Seattle, Tenpoint emphasizes functional near-vision outcomes, duration of effect, and tolerability for long-term daily use.

📋 Description

• 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

• 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

• 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