Associate Director / Director, Regulatory Affairs CMC
- Pay
- $177,399 – $238,957 per year
- Location
- Bothell, WA · On-site
- Job type
- Full-time
- Level
- Director
- Experience
- 7+ years
- Education
- Bachelor's degree
- Listed
- 31 days ago
Skills & highlights for this role
- CMC regulatory submissions
- ICH guidelines
- FDA and EMA interactions
Also useful
- Veeva RIM
Position Overview
Immunome is seeking an Associate Director / Director, Regulatory Affairs CMC, responsible for developing and executing global regulatory CMC strategies across multiple modalities. This individual will manage key deliverables and ensure adherence to accelerated regulatory submission schedules.
Reporting into the Senior Director, Regulatory Affairs CMC, the role is responsible for communications and interactions with global regulatory authorities. This person will collaborate cross-functionally with teams including Technical Operations, Quality Assurance, Supply Chain Management, and Project Management to maintain alignment with regulatory CMC strategies and compliance requirements.
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.
Qualifications
- Bachelor's degree in a relevant scientific discipline required; advanced degree a plus.
- A minimum of 7 years of relevant pharmaceutical/biotechnology industry experience, including 5+ years in regulatory CMC, or equivalent experience.
- 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.
Knowledge and Skills
- 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.
Pay and benefits
Washington State Pay Range $177,399—$238,957 USD
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 accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
Equal opportunity and legal notices
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).
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
From Immunome, Inc.'s careers page, first listed on Rolev.ai on October 10, 2026. Rolev.ai is not the employer.
How Rolev.ai helps with this application
Rolev.ai is a job search and application tool for US job seekers. For this Associate Director / Director, Regulatory Affairs CMC role at Immunome, Inc., it shows how your resume fits, tailors your resume to the posting, and prepares the application for you to review.
See how you fit
Openings from employer career sites are ranked against your whole resume—and searchable inside Claude, ChatGPT, and Cursor via Rolev.ai MCP.
Tailor without inventing
Every change to your resume is checked against your original. New experience goes in only with your yes—zero fabricated claims.
Draft the full kit
Tailored and Full Match resumes, role-specific cover letters, and answers to employer screening questions are prepared in seconds.
1-Click Extension Autofill
The Chrome extension fills the employer's Greenhouse, Workday, Lever, or Ashby form in 1 click. You review it and press Submit.
Similar roles
- (Senior) Director, Regulatory Affairs CMCBraveheart Bio · San Francisco, CA
- Senior Manager, Regulatory AffairsIntuitive · Sunnyvale, CA · $280k/yr
- SVP, Regulatory AffairsVir Biotechnology · San Francisco, CA
- Sr Manager, Global Regulatory Affairs (AI/ML)Hims & Hers · Remote (US)
- Principal Regulatory AffairsMedline · REMOTE- Illinois
- Regulatory ManagerPrecision Medicine Group · Remote (US)
Common questions
What is the salary for the Associate Director / Director, Regulatory Affairs CMC role at Immunome, Inc.?
The Associate Director / Director, Regulatory Affairs CMC posting at Immunome, Inc. states compensation of $177,399 – $238,957 per year. It is listed as a full-time position. Final pay may depend on location, experience, and interview evaluation on Immunome, Inc.'s official career site.
Where is the Associate Director / Director, Regulatory Affairs CMC job at Immunome, Inc. located?
This Associate Director / Director, Regulatory Affairs CMC position at Immunome, Inc. is located in Bothell, WA (On-site). Always check Immunome, Inc.'s application page for specific state eligibility or relocation policies.
What qualifications are required for Associate Director / Director, Regulatory Affairs CMC at Immunome, Inc.?
For the Associate Director / Director, Regulatory Affairs CMC role, Immunome, Inc. highlights 7+ years of relevant experience; a bachelor's degree; experience with CMC regulatory submissions, ICH guidelines, FDA and EMA interactions. Rolev.ai can score your existing resume against these requirements and show any skill gaps before you apply.
How do I apply for the Associate Director / Director, Regulatory Affairs CMC position at Immunome, Inc.?
This listing links directly to Immunome, Inc.'s Greenhouse application page. You can apply directly on Immunome, Inc.'s site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the Greenhouse application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.