Position OverviewThis 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.
ResponsibilitiesRegulatory 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
