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Head of Regulatory Affairs Strategy

2 months ago

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

Salary:
$220,000 to $250,000 annually

Alumis Inc is dedicated to revolutionizing the treatment landscape for patients suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous individuals with immunologic conditions still face significant challenges. Our objective is to profoundly alter the prognosis for these patients. We are in search of a highly driven professional to lead and facilitate global regulatory initiatives that align with Alumis' strategic goals for securing international approvals for our innovative therapies. This individual will act as the Regulatory Affairs representative, collaborating closely with cross-functional teams and development partners while managing relationships with external regulatory service providers in compliance with health authority and ICH standards. As a pivotal member of our project teams, this role will also provide essential organizational support as the company expands its product development pipeline. The 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 development phases.
  • Act as the Regulatory Affairs liaison on designated project teams, ensuring project progression by offering guidance, solutions, and feedback to support regulatory approvals.
  • Lead communications with regulatory agencies for assigned projects.
  • Establish and adhere to timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while preparing for global NDAs/MAAs.
  • Engage with Regulatory Affairs personnel from external service providers.
  • Stay informed about current regulatory requirements and relay necessary information to facilitate regulatory approvals.

Qualifications:

  • Bachelor's or advanced degree in a scientific field, with a minimum of 10 years of experience in drug development within the biopharmaceutical sector and 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 a history of effectively leading assigned tasks within cross-functional teams.
  • Expertise in providing strategic counsel on integrated regulatory development plans and lifecycle management.
  • Exceptional verbal and written communication abilities.
  • Collaborative, analytical, and interpretative skills that facilitate the review and compilation of reports and documents used in 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. Responsibilities may necessitate a work schedule that includes hours outside of standard business times to meet organizational demands.

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

Alumis Inc. is an equal opportunity employer. All employees must provide proof of vaccination against COVID-19, unless exempt for valid medical or religious reasons.