Associate Director, Regulatory Affairs

Immunomeinc; Bothell (WA); On-site; USD 178,219 - 212,873; Full time

Job summary

Immunomeinc in Bothell, Washington is seeking a Regulatory Affairs professional to oversee early and late-phase regulatory activities. This role focuses on ensuring compliance and supporting innovative product development in oncology.

The ideal candidate should have at least 7 years of experience in regulatory affairs, with knowledge of FDA and international guidelines being crucial. This position offers a competitive salary range of $178,219—$212,873 USD and the chance to work on cutting-edge cancer therapies.

Qualifications

• 7+ years of experience in regulatory affairs with a focus on early-phase drug development.
• Experience in preparing and submitting regulatory filings (INDs, CTAs).
• In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, ICH).

Responsibilities

• Contribute to the design and execution of global regulatory strategies.
• Prepare, review, and submit regulatory documents for clinical programs.
• Act as a primary contact for regulatory authorities (FDA, EMA).
• Work closely with cross-functional teams to ensure regulatory support.
• Train and mentor team members on regulatory processes.

Skills

Regulatory Affairs Expertise

Project Management

Interpersonal Communication

Knowledge of FDA Guidelines

Education

Bachelor’s degree in life sciences or related field

Advanced degree (PhD, PharmD, MS)

Tools

Veeva Vault

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

This key role will focus on the tactical and strategic oversight of early‑phase and late‑phase regulatory activities to ensure compliance and support innovative product development. The successful candidate will combine hands‑onexpertisein regulatory affairs with a proactive approach to solving complex challenges in clinical development.

Responsibilities

Regulatory Strategy Development

• Contribute to the design and execution of global regulatory strategies for early‑phase development programs.
• Provide regulatory guidance to cross‑functional teams, ensuring alignment with Immunome’s objectives and compliance with regulatory requirements.
• Identify and assess potential regulatory risks and develop mitigation strategies.

Tactical Implementation

• Prepare, review, and submit regulatory documents for early and late‑phase clinical programs (e.g., INDs, CTAs, amendments).
• Coordinate and oversee the preparation of technical content, including CMC, non‑clinical, and clinical sections of regulatory submissions.
• Manage timelines and ensure regulatory milestones are met.
• Serve as a subject matter expert on regulatory systems (e.g., Veeva Vault), overseeing system use in collaboration with IT and Quality, user training and data archiving.
• Contribute to department infrastructure development by initiating processes targeted towards efficiency, quality, compliance and collaboration.

Regulatory Interactions

• Act as a primary contact for regulatory authorities (e.g., FDA, EMA) for early and/or late‑phase development programs.
• Plan and participate in meetings with regulatory agencies, preparing briefing packages, and coordinating follow‑ups.
• Monitor and interpret regulatory guidelines and communicate implications to internal stakeholders.

Cross‑Functional Collaboration

• Work closely with research, development, CMC, and quality teams to ensure seamless regulatory support.
• Provide regulatory input during protocol development, study design, and data interpretation.
• Train and mentor team members on regulatory processes and requirements.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (PhD, PharmD, MS) preferred.
• 7+ years of experience in regulatory affairs with a strong emphasis on early‑phase drug development, or equivalent experience. Oncology, rare disease, or similarly complex experience is required.
• Demonstrated experience in preparing and submitting regulatory filings (e.g., INDs, CTAs).

Knowledge and Skills

• In‑depth knowledge of regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
• Proven ability to manage multiple projects and priorities in a fast‑paced environment.
• Strong interpersonal and communication skills, with experience engaging regulatory agencies.
• Experience with immunotherapies or biologics is highly desirable.

Washington State Pay Range

$178,219—$212,873 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).