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Immunome, Inc. · 4 hours ago

Director/Associate Director, Regulatory Affairs CMC

Bothell, WA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$165K/yr - $208K/yr

7+ years exp

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. They are seeking a Director/Associate Director, Regulatory Affairs CMC, responsible for developing and executing global regulatory CMC strategies and managing key deliverables while ensuring compliance with regulatory requirements.

BiopharmaBiotechnologyMedicalPharmaceutical

Responsibilities

Develop and execute global regulatory CMC strategies across clinical and commercial stages

Serve as the regulatory CMC lead on cross-functional teams, providing strategic input to technical operations, supply chain, quality and project teams

Author, review and manage the preparation of high-quality CMC sections for regulatory submission (e.g. IND, CTAs, IMPD, annual reports, pediatric plans, amendments, and marketing applications)

Lead interactions with global health authorities on CMC topics, including preparation of briefing packages, responses to information requests, and representation at meetings

Collaborate with internal and external stakeholders to ensure regulatory compliance and alignment with regulatory CMC strategies

Maintain current knowledge of regulations and guidelines (e.g., ICH, FDA, EMA) and keep abreast of changes in the global regulatory environment

Support regulatory inspections, as required

Qualification

Regulatory CMC strategyCMC submission preparationICHFDAEMA guidelinesPharmaceutical/biotechnology experienceSubmission management softwareAnalytical skillsFlexible work styleCommunication skillsOrganizational skillsTime management skillsLeadership abilitiesAttention to detail

Required

Bachelor's degree in a relevant scientific discipline

A minimum of 7 years of relevant pharmaceutical/biotechnology industry experience

5+ years in regulatory CMC

Hands-on experience with CMC submission preparation for small molecules, biologics, and/or antibody-drug conjugates

Experience with regulatory CMC strategy development and health authority interactions

Deep understanding of ICH, FDA and EMA guidelines

Outstanding communication, analytical, organizational and time management skills

Strong written and verbal communication abilities with attention to detail

Ability to effectively lead cross-functional teams

Flexible work style with a pragmatic approach to rapidly changing priorities

Proficiency in submission management software, such as Veeva RIM

Preferred

Advanced degree

Company

Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.

Founded in 2008

Exton, Pennsylvania, USA

51-200 employees