Vice President, Regulatory Science

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November 6

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Day One Biopharmaceuticals

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Day One Biopharmaceuticals is a company dedicated to developing and advancing medicines for patients, with a strong focus on pediatric low-grade glioma (pLGG) and pediatric cancer research. The company is committed to improving the lives of cancer patients of all ages by providing access to innovative therapies. Their pipeline includes FDA-approved medicines for pediatric oncology, and they actively engage in clinical trials, scientific publications, and research collaborations to drive progress in cancer treatment and drug development. Their mission emphasizes collaboration with stakeholders to redefine possibilities for people living with cancer from day one.

11 - 50 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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)

🎯 Requirements

• At a minimum, a BA/BS degree; Master’s/PhD/PharmD in life sciences preferred. • 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 Liscence 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.

🏖️ Benefits

• Please visit https://www.dayonebio.com/benefits to see our competitive benefits.