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Head of Regulatory Affairs Strategy

2 months ago

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

Salary:
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 dramatically improve patient outcomes. We are in search of a highly driven professional to lead and support our global regulatory initiatives, aligning with Alumis' strategic goals to secure international approvals for our innovative products. This role will involve representing Regulatory Affairs and collaborating closely with cross-functional teams and development partners, while also managing relationships with external regulatory service providers in compliance with health authority and ICH standards. As a pivotal member of our project teams, you will provide essential organizational support as our company and product development pipeline expand. This position reports directly to the Executive Director and Head of Regulatory Strategy.


Key Responsibilities:

  • Formulate and execute regulatory strategies to advance assigned programs throughout all development phases.
  • Act as the Regulatory Affairs representative on designated project teams, ensuring project progression by offering guidance, solutions, and feedback to facilitate regulatory approvals.
  • Lead communications with regulatory bodies for assigned programs.
  • Set 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 effectively communicate these requirements 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 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.
  • In-depth 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 effectively leading assigned tasks within cross-functional teams.
  • Ability to provide strategic insights on integrated regulatory development plans and lifecycle management.
  • Exceptional verbal and written communication skills.
  • Strong collaborative, analytical, and interpretative skills for reviewing and compiling reports and documents for regulatory planning and submissions.
  • Capability to work independently, prioritize tasks to meet deadlines, and motivate and influence team members; prior management experience is advantageous.
  • Willingness to travel as necessary. Responsibilities may require a flexible work schedule to meet business needs.

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

Alumis Inc. is an equal opportunity employer. If you are hired, we will require you to prove that you have received the primary series of an FDA-approved or authorized COVID-19 vaccine and at least one booster or have a valid religious or medical reason not to be vaccinated.