Associate Director, Regulatory Affairs
Immunome, Inc.
9 days ago
Remote friendly (Bothell, WA)
United States
Corporate Functions
Position Overview:
This key role focuses on tactical and strategic oversight of early-phase and late-phase regulatory activities to ensure compliance and support innovative product development.
Responsibilities:
- Contribute to design and execution of global regulatory strategies for early-phase development programs.
- Provide regulatory guidance to cross-functional teams to ensure alignment and compliance.
- Identify and assess 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 preparation of technical content (CMC, non-clinical, and clinical sections).
- Manage timelines and ensure regulatory milestones are met.
- Serve as a subject matter expert on regulatory systems (e.g., Veeva Vault), overseeing system use with IT and Quality, user training, and data archiving.
- Initiate processes to improve efficiency, quality, compliance, and collaboration.
- Act as primary contact for regulatory authorities (e.g., FDA, EMA).
- Plan and participate in regulatory meetings; prepare briefing packages and coordinate follow-ups.
- Monitor and interpret regulatory guidelines and communicate implications.
- Work with research, development, CMC, and quality teams to ensure 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 regulatory affairs experience with strong emphasis on early-phase drug development; oncology, rare disease, or similarly complex experience required.
- Demonstrated experience preparing and submitting regulatory filings (e.g., INDs, CTAs).
Knowledge and Skills:
- In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Strong interpersonal and communication skills; experience engaging regulatory agencies.
- Experience with immunotherapies or biologics highly desirable.
This key role focuses on tactical and strategic oversight of early-phase and late-phase regulatory activities to ensure compliance and support innovative product development.
Responsibilities:
- Contribute to design and execution of global regulatory strategies for early-phase development programs.
- Provide regulatory guidance to cross-functional teams to ensure alignment and compliance.
- Identify and assess 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 preparation of technical content (CMC, non-clinical, and clinical sections).
- Manage timelines and ensure regulatory milestones are met.
- Serve as a subject matter expert on regulatory systems (e.g., Veeva Vault), overseeing system use with IT and Quality, user training, and data archiving.
- Initiate processes to improve efficiency, quality, compliance, and collaboration.
- Act as primary contact for regulatory authorities (e.g., FDA, EMA).
- Plan and participate in regulatory meetings; prepare briefing packages and coordinate follow-ups.
- Monitor and interpret regulatory guidelines and communicate implications.
- Work with research, development, CMC, and quality teams to ensure 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 regulatory affairs experience with strong emphasis on early-phase drug development; oncology, rare disease, or similarly complex experience required.
- Demonstrated experience preparing and submitting regulatory filings (e.g., INDs, CTAs).
Knowledge and Skills:
- In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Strong interpersonal and communication skills; experience engaging regulatory agencies.
- Experience with immunotherapies or biologics highly desirable.