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Senior Manager of Regulatory Affairs (Contract)

Alumis Inc.South San Francisco
On-site Contract $165K/yr - $195K/yr

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Experience Level

Senior Level Manager

Qualifications

EDUCATION/EXPERIENCE/SKILLS:Bachelor’s degree or higher in a scientific discipline, with no less than 5 years of experience in drug development within the biopharmaceutical industry, including at least 3 years in Regulatory Affairs. Experience in immunology or orphan drug development is highly desirable. Knowledge/Skills/Abilities:Proven experience with global pharmaceutical regulatory submissions and contributions to significant regulatory filings such as INDs and CTAs. Solid understanding of FDA regulations and practices, ICH guidelines, and comprehensive knowledge of global health authority regulations.

About the job

Alumis Inc. is at the forefront of precision medicine, dedicated to revolutionizing the lives of patients battling autoimmune diseases. Despite the advancements in treatments over the last twenty years, many individuals with immunologic conditions continue to face significant challenges. Our mission is to fundamentally improve outcomes for these patients through innovative solutions.

We are in search of an exceptionally driven professional to lead and support our global regulatory initiatives, aligning with Alumis’ strategic objectives to secure worldwide marketing approvals for our innovative products. The successful candidate will represent the Regulatory Affairs department and collaborate closely with cross-functional project teams and regulatory service providers, ensuring compliance with health authority guidelines and ICH standards. As a vital member of our project teams, the individual will also provide organizational support as the company and its product development pipeline expand. This position reports directly to the Director of Regulatory Strategy.

ESSENTIAL DUTIES & RESPONSIBILITIES

  • Act as the Regulatory Affairs representative for Phase 1 through Phase 3 clinical trials, ensuring that all regulatory activities are properly evaluated, prioritized, and executed in alignment with global regulatory mandates.
  • Serve as the Regulatory Affairs representative on designated study teams, facilitating the progress of studies by addressing regulatory inquiries to support approval processes.
  • Lead the preparation, review, and submission of Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), amendments, and manage other regulatory tasks as necessary throughout assigned studies.
  • Establish and adhere to timelines for regulatory submissions related to INDs/CTAs, encompassing nonclinical, clinical, and Chemistry, Manufacturing, and Controls (CMC) operations while planning for Phase 1 to 3 trials.
  • Engage with Contract Research Organizations (CROs) to manage regulatory affairs effectively.
  • Maintain up-to-date knowledge of current regulatory requirements and communicate these effectively to support regulatory approvals.

About Alumis Inc.

At Alumis Inc., we are committed to developing precision medicines that make a difference in the lives of patients suffering from autoimmune diseases. Our innovative approach aims to transform the treatment landscape and improve the quality of life for those affected by these conditions.

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