Associate Director, Regulatory Affairs

Immunome, Inc.•Bothell, WA

2h•$178,219 - $212,873

About The Position

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-on expertise in regulatory affairs with a proactive approach to solving complex challenges in clinical development.

Requirements

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.
Oncology, rare disease, or similarly complex experience is required.
Demonstrated experience in preparing and submitting regulatory filings (e.g., INDs, CTAs).
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.

Nice To Haves

Experience with immunotherapies or biologics is highly desirable.

Responsibilities

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.
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.
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.
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.