Head of Regulatory Affairs

2 weeks ago

Mountain View, California, United States IGM Biosciences, Inc. Full time

About IGM Biosciences, Inc.

IGM Biosciences (Nasdaq: IGMS) is a pioneering biotechnology firm in the clinical stage, dedicated to innovating and providing a novel class of therapeutics aimed at treating patients afflicted with cancer as well as autoimmune and inflammatory disorders. Our pipeline encompasses both clinical and preclinical assets centered around the IgM antibody, which boasts 10 binding sites, unlike the conventional IgG antibodies that possess only 2. We have engineered distinctive IgM antibodies characterized by high selectivity, affinity, and avidity, potentially transforming the landscape of therapeutic antibody treatments. Our proprietary IgM antibody technology platform is particularly adept at developing T cell engagers and receptor cross-linking agonists. Additionally, we maintain an exclusive global collaboration with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists targeting oncology, immunology, and inflammation. For further details, please visit our website.

IgM Antibodies and Autoimmune and Inflammatory Diseases

Antibody therapies have significantly enhanced patient outcomes in the realm of autoimmune and inflammatory diseases. We are devoted to investigating how the unique structure and binding characteristics of our IgM antibody platform can further improve the prognosis for patients suffering from these severe conditions.

Position Overview:

The Director of Regulatory Affairs will serve as the global regulatory lead (GRL) for multiple initiatives. This role entails crafting the global regulatory strategy in conjunction with essential internal stakeholders and tactically executing that strategy to support IGM's expanding portfolio of programs.

This position collaborates cross-functionally with Regulatory Affairs and the clinical development team to ensure the timely completion of regulatory filing documentation in alignment with company timelines. It also guarantees compliance with pertinent regulatory standards and company Standard Operating Procedures (SOPs) as necessary.

Key Responsibilities:

  • Formulate and execute competitive and effective global regulatory strategies for various immunology products, encompassing clinical, nonclinical, and CMC elements, while identifying potential risks and mitigation strategies linked to proposed strategies.
  • Collaborate closely with the development team leader and other cross-functional colleagues, including CROs, to devise sound, efficient development strategies and operational plans.
  • Oversee and manage the development and preparation of high-quality global submissions (including IND, CTAs, BLAs, and MAAs) for IGM's early and late-stage programs in partnership with regulatory and project teams to facilitate and expedite clinical development and regulatory approval.
  • Represent Regulatory Affairs on assigned cross-functional development teams.
  • Lead communication with global Health Authorities (HA), such as FDA and EMA, including planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
  • Provide updates on strategic global regulatory intelligence, including new regulations, guidance, competitive product applications, approvals, and their implications for IGM programs.
  • Anticipate challenges and guide cross-functional teams on risk mitigation strategies for any development obstacles.

Qualifications:

  • Level is commensurate with experience
  • A minimum of 10 years of experience in Regulatory Affairs within the biopharma sector; substantial experience in the therapeutic area of immunology/autoimmunity is highly preferred.
  • BS or higher degree in the life sciences; an advanced academic degree (Master's or PhD) is advantageous.
  • Experience as a GRL providing strategic regulatory guidance to project teams throughout all stages of product development.
  • Extensive experience in filing IND/CTAs and some familiarity with BLAs/NDAs/MAAs.
  • Comprehensive knowledge of regulatory requirements across all stages of drug development in a global context.
  • Demonstrated success in proactively managing collaborative relationships with key internal and external stakeholders, including FDA and other Health Authorities.
  • Proven capability to successfully lead regulatory meetings.
  • Ability to work independently and exhibit innovation in addressing strategic and operational challenges.
  • Experience in managing direct reports is preferred.
  • Must possess strong verbal and written communication skills.
  • Proficiency with computer and standard software applications utilized in Regulatory Affairs is essential.

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