Day One Biopharmaceuticals · 1 week ago
Vice President, Regulatory Science
United States
Full-time
Remote
Director/Executive
$325K/yr - $345K/yr
15+ years expDay One Biopharmaceuticals is focused on advancing first- or best-in-class medicines for childhood and adult diseases. The Vice President, Regulatory Science will oversee the Regulatory Strategy, Medical Writing, Regulatory Operations, and other regulatory functions while ensuring compliance and maintaining global regulatory strategies across all phases of drug development.
BiopharmaBiotechnologyHealth CarePharmaceutical
No H1B
Responsibilities
Develop, implement and maintain global regulatory strategies across all phases of drug development from IND/CTA preparation through product approval and the post-marketing setting
Further build the regulatory and quality functions, build, and maintain strong leadership capabilities at all levels within the team and support the professional development of team members
Oversee U.S. / international submissions and strategic interactions with Health Authorities
Oversee submission and maintenance of global regulatory filings
Assure compliance with relevant regulations and guidelines
Communicate with and manage consultants, CROs, and other vendors
Develop regulatory strategies and submission plans to achieve submission milestones and marketing authorization in support of development timelines and corporate goals
Oversee regulatory activities, including the preparation, review and submission of regulatory documents such as meeting requests, briefing documents, Health Authority responses, clinical trial / marketing applications, pediatric plans, product labeling
Submission and life-cycle maintenance of US and international regulatory filings
Oversee and have accountability for CMC Regulatory Submissions
Perform other duties as required, interfacing with other departments, CROs and external vendors as needed
Act as primary point of contact for external collaborations (e.g. ex-US markets)
Qualification
Required
At a minimum, a BA/BS degree
At least 15 years of experience in pharma/biotech industry in Regulatory Science, overseeing internal and vendor staff
Experience in building teams and managing people
Strong strategic and analytical abilities
Working knowledge of the Code of Federal Regulations and FDA, EMA and ICH guidelines
Expert knowledge of FDA and ICH GxP regulations and guidelines, across all disciplines including GLP, GCP, and GVP
FDA Investigational New Drug Applications (IND), New Drug Applications (NDA), Biologics License Application (BLA) and Drug Master Files (DMF) submission experience
NDA / CTD dossier preparation, management and submission experience
Product label development and management experience
Knowledge and understanding of product life-cycle post-approval management
Ability to help shape key department goals and objectives, drive process and operational efficiencies, and contribute to ongoing development of innovative best practices both internally and with cross-functional colleagues
Ability to work independently, establish priorities, and execute with minimal guidance
Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment
Excellent interpersonal, communication, analytical, and organizational skills
Preferred
Master's/PhD/PharmD in life sciences
Company
Day One Biopharmaceuticals
Day One Biopharmaceuticals develops targeted therapies to treat people with life-threatening diseases.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$687.5MKey Investors
RA Capital Management
2024-07-30Post Ipo Equity· $175M
2023-06-06Post Ipo Equity· $150M
2022-06-14Post Ipo Equity· $172.5M
Leadership Team
Jeremy Bender
Chief Executive Officer
Heather Huet
Chief Scientific Officer
Recent News
2026-01-13
Investor's Business Daily
2026-01-13
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