Tenpoint is a global commercial-ready biotech developing groundbreaking treatments to rejuvenate vision in the aging eye
Director – Regulatory Affairs
Location
United States
Posted
10 hours ago
Salary
$230K - $300K / year
Seniority
Senior
Job Description
Director – Regulatory Affairs
Tenpoint Therapeutics, Ltd.
• 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.
Job 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
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