200+ applicants

Company

IGM Biosciences, Inc. · 3 days ago

Director / Sr. Director, Regulatory Affairs

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$215K/yr - $280K/yr

10+ years exp

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Hiring Manager

Janaye Ruhl

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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.

Qualification

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Immunology experienceRegulatory Affairs experienceGlobal Regulatory Lead (GRL)IND/CTA filing experienceRegulatory requirements knowledgeBLA/NDA/MAA experienceLife sciences degreeStakeholder managementRegulatory meetings leadershipComputer proficiency

Required

Must have relevant immunology therapeutic area experience.

A minimum of 10 years of Regulatory Affairs experience in the biopharma industry.

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 Authority divisions most relevant to our work including Rheumatology.

Proven ability to successfully lead regulatory meetings.

Ability to work independently and to be innovative in tackling strategic and operational challenges.

Must have strong verbal and written communication skills.

Must be proficient with computer and standard software programs used in Regulatory Affairs.

Preferred

autoimmunity and/or rheumatology is strongly preferred.

Experience managing direct reports is preferred.

Company

IGM Biosciences, Inc.

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company pioneering the development of engineered IgM antibodies for the treatment of cancer, infectious diseases, and autoimmune and inflammatory diseases.

Founded in 2010

Mountain View, California, USA

201-500 employees

https://igmbio.com

H1B Sponsorship

IGM Biosciences, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

2023 (4)

2022 (3)

2021 (7)

2020 (5)