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Director of Regulatory Affairs

3 months ago

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

About IGM Biosciences, Inc.

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer and autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites, compared to conventional IgG antibodies with only 2 binding sites. We have created unique IgM antibodies with high selectivity, affinity, and avidity that may redefine what is possible for therapeutic antibody medicines. We believe our proprietary IgM antibody technology platform is particularly well suited for developing T cell engagers and receptor cross-linking agonists. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology, immunology, and inflammation targets. For more information, please visit .

IgM Antibodies and Autoimmune and Inflammatory Diseases

Antibody treatments have revolutionized outcomes for patients with autoimmune and inflammatory diseases. We are committed to exploring how our IgM antibody platform's unique structure and binding properties can improve outcomes for patients with these serious conditions.


Position Description:

The Director of Regulatory Affairs will be the global regulatory lead (GRL) on several programs. They will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders and tactically implementing that strategy for IGM's growing pipeline of programs.

This position works cross-functionally with Regulatory Affairs and the clinical development organization to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required.


Responsibilities:

  • Develop and implement competitive and effective global regulatory strategies for various immunology products, including clinical, nonclinical, and CMC aspects, and identify potential risks and mitigation strategies associated with proposed strategies
  • Work in close collaboration with the development team leader and other cross-functional colleagues, including CROs, to deliver sound, efficient development strategies and operational plans
  • Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, BLAs, and MAAs) for IGM early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate 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, such as new regulations, guidance, competitive product applications, approvals, and their impact on IGM programs.
  • Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges.


Qualifications:

  • Level is commensurate with experience
  • A minimum of 10 years of Regulatory Affairs experience in the biopharma industry; Significant experience in the therapeutic area of immunology/autoimmunity is strongly preferred
  • BS or higher degree in the life sciences; Advanced academic degree (Master’s or PhD) is a plus
  • Experience as a GRL providing strategic regulatory advice to project teams for the global development of products through all stages of development.
  • Extensive experience filing IND/CTAs and some experience with BLAs/NDAs/MAAs
  • Extensive knowledge of regulatory requirements for all stages of drug development in a global environment
  • Demonstrated success in proactively managing collaborative relationships with key internal and external stakeholders, including FDA and other Health Authorities
  • Proven ability to successfully lead regulatory meetings
  • Ability to work independently and to be innovative in tackling strategic and operational challenges
  • Experience managing direct reports is preferred
  • Must have strong verbal and written communication skills
  • Must be proficient with computer and standard software programs used in Regulatory Affairs