Associate Director / Director, Regulatory Affairs CMC

Immunomeinc; Bothell (WA); On-site; USD 177,000 - 239,000; Full time

Job summary

Immunome, Inc. in Bothell, WA is seeking an Associate Director / Director, Regulatory Affairs CMC to lead global regulatory CMC strategies across modalities.

You will manage key deliverables and coordinate with Technical Operations, Quality Assurance, Supply Chain, and Project Management to align with regulatory expectations. This role requires a strong track record in regulatory CMC submissions (IND, CTAs, IMPD) and ongoing health authority interactions, with a focus on timely filings and

Qualifications

• Bachelor’s degree in a relevant scientific discipline required.
• Advanced degree a plus.
• 7+ years of pharmaceutical/biotechnology experience including 5+ years in regulatory CMC.
• Hands-on experience with CMC submission preparation for small molecules, biologics, and/or antibody-drug conjugates.

Responsibilities

• Develop and execute global regulatory CMC strategies across modalities.
• Lead cross-functional teams and provide strategic input to operations, QA, supply chain, and project teams.
• Author, review and manage CMC submission sections (IND, CTAs, IMPD, annual reports).
• Lead interactions with global health authorities and prepare briefing packages.

Skills

Regulatory CMC

CMC submissions

Health authority interactions

Cross-functional leadership

Communication skills

Attention to detail

Education

Bachelor’s degree in a relevant scientific discipline

Advanced degree is a plus

Job description

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

Immunome is seeking anAssociate Director / Director, Regulatory Affairs CMC, responsible for developing and executing global regulatory CMC strategies across multiple modalities. This individual willmanagekey deliverables and ensure adherence to accelerated regulatory submission schedules.Reporting into the Senior Director, Regulatory Affairs CMC, theroleis responsible forcommunications and interactions with global regulatory authorities. This personwill collaborate cross-functionally with teams including Technical Operations, Quality Assurance, Supply Chain Management, and Project Management tomaintainalignment with regulatory CMC strategies and compliance requirements.

Responsibilities

• Develop andexecuteglobalregulatory CMC strategiesacross clinical and commercial stages.

• Serve as the regulatory CMC lead oncross-functional teams, providing strategic input to technicaloperations, supply chain,qualityand 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, asrequired.

Qualifications

• Bachelor’s degree inarelevant scientific disciplinerequired; advanced degreea plus.

• A minimum of7years of relevantpharmaceutical/biotechnologyindustry experience, including 5+years inregulatory CMC, or equivalent experience.

• Hands-on experience with CMC submission preparation forsmall molecules,biologics, and/or antibody-drug conjugates.

• Experience with regulatory CMC strategy development and health authority interactions.

Knowledge and Skills

• Deep understanding of ICH,FDAand EMA guidelines.

• Outstandingcommunication, analytical,organizationaland 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 torapidly changingpriorities.

• Proficiencyin submission management software, such as Veeva RIM.

Washington State Pay Range

$177,399—$238,957 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

E-Verify

Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).