Principal Specialist, Health Authorities
ImmunityBio•Summit, NJ
•Onsite
About The Position
The Principal Specialist, Health Authorities assists in developing global clinical regulatory strategy for investigational and marketed products and in preparing, reviewing, and finalizing regulatory submission packages and responses to Health Authorities. The role provides high-level regulatory clinical science expertise to ensure submissions conform to local Health Authority requirements. It is an on-site, desk-based position in Summit, New Jersey, involving close review of scientific and regulatory documents and collaboration with scientific colleagues and project teams.
Requirements
- Bachelor’s degree in life sciences or a technical discipline and 10 or more years of relevant progressive experience, or a master’s degree in life sciences or a technical discipline and 8 or more years of relevant progressive experience.
- Experience preparing clinical modules for submission in eCTD format.
- Familiarity with organizing responses to Health Authority information requests.
- Strong knowledge of Health Authority clinical guidance documents and requirements.
- Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines.
- Strong knowledge of clinical documentation.
- Ability to meet firm deadlines and adapt quickly to changing requirements and priorities.
- Strong organizational, written and oral communication, and attention-to-detail skills.
- Ability to manage multiple changing deadlines and operate in ambiguous situations.
Nice To Haves
- Familiarity with regulatory submissions outside the United States.
Responsibilities
- Evaluate clinical data, reports, and summaries for compliance with protocols, statistical analysis plans, monitoring guidelines, data management plans, and other clinical-trial documents.
- Assemble reports of clinical studies sponsored by IBRX.
- Draft and finalize regulatory submission documents, including INDs, CTAs, NDAs, BLAs, MAAs, briefing books, and other application documents.
- Prepare responses to Health Authority comments and questions concerning clinical issues.
- Support version-control governance by supervising a centralized document repository, applying naming-convention standards, authorizing change-tracking procedures, and assisting with final module versions before electronic upload.
- Provide guidance, training, and expert opinions to others on the preparation, analysis, and documentation of studies.
- Monitor and analyze emerging Health Authority guidance, anticipate regulatory shifts, and advise cross-functional teams.
- Perform ad hoc and cross-functional duties or projects as assigned to support business needs and provide developmental opportunities.
Benefits
- Medical, dental, and vision plan options
- Health and financial wellness programs
- Employee Assistance Program (EAP)
- Company-paid and voluntary life and AD&D insurance
- Short-term and long-term disability
- Healthcare and dependent care flexible spending accounts
- 401(k) retirement plan with company match
- 529 education savings program
- Voluntary legal services
- Identity theft protection
- Pet insurance
- Employee discounts, rewards, and perks
- Paid time off, including 11 holidays
- Unlimited PTO for exempt employees
- For non-exempt employees: 10 vacation days, 56 hours of health pay, 2 personal days, and 1 cultural day
- Discretionary bonus and equity award
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What This Job Offers
Job Type
Full-time
Career Level
Principal
