Manager/Sr. Manager, Regulatory Affairs

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Job description

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. IgM antibodies have inherent properties that we believe may enable them to improve upon the efficacy and safety of IgG antibodies in multiple therapeutic applications.

We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists, and targeted cytokines. Our lead product candidate, IGM-2323, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3, and we have initiated a Phase 1 clinical trial for the treatment of relapsed/refractory B cell Non-Hodgkin's lymphoma (NHL) patients in 2019. Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with solid and hematologic malignancies, for which we have recently initiated a Phase 1 clinical trial. Also, in our product pipeline is IGM-7354, a bispecific IgM antibody delivering interleukin-15 (IL-15) cytokines to PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies.

As Manager/Sr. Manager, Regulatory Affairs, you will provide regulatory support for the development and implementation of global regulatory strategies and activities that are critical to the success of IGM's growing pipeline of programs. These activities include managing global filing, supporting Health Authority (HA) interactions, developing processes, creating and managing filing timelines and tracking submissions. This position will report into the VP of regulatory affairs.

Responsibilities:

* Manage the preparation, review, submission and maintenance of global Regulatory applications including INDs/CTAs/CTNs, BLAs/NDAs in compliance with department and regulatory requirements and guidelines.
* Manage the preparation, review, submission and maintenance of applications for Orphan Drug Designation, Breakthrough and Fast Track Designations, PRIME and Sakigake.
* Lead the regulatory review and submission of ICF review, clinical site packages, annual reports, and pharmacovigilance-related submissions.
* Support the strategy and preparation for health authority meetings including preparation and submission of meeting requests/briefing books, preparation for the meetings and responses to requests for information under the direction of the RA VP
* Contribute to regulatory strategy, including identifying and communicating potential risks and mitigation plans associated with regulatory strategies
* Evaluate documents for submission to Regulatory Agencies to assure that they are complete, accurate, organized, of high quality, and compliant with company SOPs and applicable (domestic and international regulations.
* Provide oversite and serve as the primary interface with regulatory operations CRO and submission teams to ensure efficient production of high-quality regulatory documents and compiled submissions while meeting defined submission timelines
* Establish and maintain submission planners and associated timelines, facilitate tactical submission team meetings, and represent Regulatory on study management teams for assigned products
* Develop and maintain compliant archives for tracking all global regulatory submissions and correspondence with Health Authorities
* Contribute to the development and maintenance of the Regulatory Affairs SOPs and working practices to support compliance and continuous process improvements
* Support the development and maintenance of regulatory document templates
* Maintain current knowledge of FDA and international regulations, guidances, and standards applicable to company products and provide regulatory guidance to cross- functional stakeholders regarding clinical industry and regulatory trends

Qualifications:

* Minimum of 3 years industry experience in regulatory affairs or regulatory operations (minimum of 5 years for the Sr. Manager level)
* BS or higher degree in the life sciences
* General knowledge of regulatory requirements for drug development and approval
* Experience leading submission teams
* Experience filing IND/CTAs/CTNs. (Some experience with BLAs/NDAs/MAAs is a plus)
* Experience in effective collaboration with multiple stakeholders both internally and externally including Health Authorities and CROs. (Experience in managing Contract Research Organization is a plus)
* Ability to work independently and to be innovative in tackling strategic and operational challenges
* Strong verbal and written communication skills
* Proficient with computer and standard software programs

We offer a fast-paced, collaborative, team-based, and family-like work environment.

One of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we offer comprehensive benefits with a variety of options:

* Medical, dental and vision insurance.
* The full premium amount for our employees and their dependents is covered by IGM
* FSA (Flexible Spending Account)
* STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance
* 401(k) Plan
* 120 hours of Paid Time Off, 5 sick days per year, 10 holidays
* Cell phone & internet subsidy
* Employee Referral Bonus Program
* Annual training budget for professional development
* Commuter Benefit
* Annual bonus program
* New hire stock options

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.