Head of Regulatory Affairs Strategy

1 week ago

South San Francisco, California, United States Alumis Full time
Position Overview

Alumis Inc. is a pioneering company in precision medicine dedicated to improving the lives of individuals suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face significant challenges. Our mission is to fundamentally enhance the outcomes for these patients. We are in search of a highly driven professional to lead and support our global regulatory initiatives, aligning with Alumis' strategic objectives to secure worldwide approvals for our innovative products.

This role will involve representing Regulatory Affairs and collaborating closely with cross-functional teams and development partners. The successful candidate will manage relationships with external strategic and technical regulatory service providers, ensuring compliance with health authority and ICH standards. As a vital member of our project teams, you will provide organizational support as the company expands its product development pipeline. This position reports directly to the Executive Director and Head of Regulatory Strategy.


Key Responsibilities

  • Formulate and execute regulatory strategies to advance assigned programs through all stages of development.
  • Act as the Regulatory Affairs representative on designated project teams, ensuring project progress by offering guidance, solutions, and feedback to facilitate regulatory approvals.
  • Lead communications with regulatory agencies for assigned programs.
  • Establish and adhere to timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while preparing for global NDAs/MAAs.
  • Collaborate with Regulatory Affairs personnel from external service providers.
  • Stay informed about current regulatory requirements and communicate these to support regulatory approvals.

Qualifications

  • A Bachelor’s or advanced degree in a scientific field, with a minimum of 10 years of experience in drug development within the biopharmaceutical sector, including at least 8 years in Regulatory Affairs; experience in immunology or orphan drug development is preferred.

Skills and Competencies

  • Proven experience with pharmaceutical regulatory submissions and product approvals, contributing to significant regulatory filings such as IND/CTA or NDA/BLA/MAA.
  • Comprehensive understanding of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations.
  • Experience in leading interactions with regulatory agencies.
  • Demonstrated leadership and success in managing regulatory activities, with prior experience in leading cross-functional teams.
  • Expertise in providing strategic advice on integrated regulatory development plans and lifecycle management.
  • Exceptional verbal and written communication skills.
  • Collaborative, analytical, and interpretative skills that facilitate the review and compilation of reports and documents for regulatory planning and submissions.
  • Ability to work independently, prioritize tasks to meet deadlines, and motivate and influence team members; prior management experience is advantageous.
  • Willingness to travel as required, with responsibilities that may necessitate working outside of standard hours to meet business needs.

Alumis Core Values
• We Elevate
• We Challenge
• We Nurture

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

Alumis Inc. is an equal opportunity employer. Candidates will be required to demonstrate proof of receiving the primary series of an FDA-approved or authorized COVID-19 vaccine and at least one booster, or provide a valid religious or medical exemption.

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