Director of Regulatory Compliance
6 days ago
We are seeking an experienced Regulatory Strategy Director to join our team at Alumis Inc. in South San Francisco, CA. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing regulatory strategies to facilitate the progress of assigned programs in all phases of development.
Key Responsibilities- Regulatory Strategy Development: Develop and implement regulatory strategies to facilitate the progress of assigned programs in all phases of development.
- Regulatory Affairs Representation: Serve as the Regulatory Affairs representative on assigned project teams and assure the progress of projects by providing direction, solutions and feedback to the teams in support of regulatory approvals.
- Regulatory Agency Interactions: Lead interactions with regulatory agencies for assigned programs.
- Regulatory Submissions: Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for global NDAs / MAAs.
- Regulatory Partnerships: Interact with Regulatory Affairs personnel within external service providers.
- Regulatory Knowledge Management: Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.
- Education: Bachelors or advanced degree in a scientific discipline.
- Experience: Minimum of 10 years of experience working in drug development in the biopharmaceutical industry and at least 8 years of experience in Regulatory Affairs.
- Skills: Direct experience with pharmaceutical regulatory submissions and product approvals, contributing to major regulatory filing(s) such as IND/CTA or NDA/BLA/MAA. Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
- Competitive Salary: The salary range for this position is $220,000 USD to $250,000 USD annually.
- Opportunity to Work with a Leading Biopharmaceutical Company: Alumis Inc. is a precision medicines company with a mission to transform the lives of patients with autoimmune diseases.
- Collaborative Work Environment: Our team is collaborative and analytical, with a focus on delivering high-quality results.
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