Director, Regulatory Affairs - Immunology

September 26

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IGM Biosciences, Inc.

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Cancer Immunotherapy • Engineered Therapeutics • Engineered IgM Antibodies • Infectious Disease • Autoimmunity

201 - 500

💰 $200M Post-IPO Equity on 2022-03

Description

• IGM Biosciences is a clinical-stage biotech developing IgM antibodies for cancer and autoimmune diseases. • The Director of Regulatory Affairs will serve as the global regulatory lead on immunology programs. • Responsible for developing and implementing global regulatory strategies and managing quality submissions. • Collaborate cross-functionally to ensure timely regulatory filings and compliance with relevant regulations.

Requirements

• Level is commensurate with experience • Must have relevant immunology therapeutic area 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

Benefits

• Medical, dental and vision insurance. • STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance • 401(k) Plan with Employer Match • 3 Weeks of Paid Time Off, 5 sick days per year, 12 holidays • Cell phone & internet subsidy • Employee Referral Bonus Program • Annual training budget for professional development • Commuter Benefit • Annual bonus program • New hire stock • ESPP (Employee Stock Purchase Plan)