Regulatory Affairs Director

1 day ago

South San Francisco, California, United States Alumis Full time
Job Title: Regulatory Affairs Director

Alumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. We are seeking an exceptional individual to provide leadership and support to global regulatory activities, driving our strategic vision for obtaining worldwide approvals to market our products.

Key Responsibilities:

  • Develop and implement regulatory strategies to facilitate progress for assigned programs in all phases of development.
  • Represent Regulatory Affairs on assigned project teams, ensuring the progress of projects by providing direction, solutions, and feedback to the teams in support of regulatory approvals.
  • Lead interactions with regulatory agencies for assigned programs.
  • Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for global NDAs/MAAs.
  • Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.

Requirements:

  • Bachelor's or advanced degree in a scientific discipline, with a minimum of 10 years of experience working in drug development in the biopharmaceutical industry and at least 8 years of experience in Regulatory Affairs; immunology or rare disease/orphan drug development experience desirable.
  • 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.
  • Experience leading regulatory agency interactions.
  • Demonstrated leadership and success in management of regulatory activities and previous experience in successfully leading assigned activities within cross-functional teams.
  • Experience in providing strategic advice on integrated regulatory development plans and life cycle management.
  • Excellent verbal and written communication skills.
  • Collaborative, analytical, and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions.
  • Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others; prior management experience a plus.

Alumis Values:

  • We Elevate
  • We Challenge
  • We Nurture

This position is located in South San Francisco, CA. At this time, we are not considering remote applicants.

The salary range for this position is $220,000 USD to $250,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices.

Alumis Inc. is an equal opportunity employer.

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