Principal Specialist, Health Authorities
ImmunityBio•Summit, NJ
•Onsite
About The Position
The Principal Specialist, Health Authorities will assist in the development of global clinical regulatory strategy for investigational and marketed products and assist with the preparation, review, and finalization of submission packages and responses to Health Authorities. The Principal Specialist, Regulatory Clinical Science will provide a high-level of expertise to the organization in ensuring the regulatory submissions conform to local Health Authority requirements.
Requirements
- Bachelor’s Degree in life sciences life sciences or technical discipline with 10+ years of relevant progressive experience required; or Master’s degree in life sciences or technical discipline with 8+ years of relevant progressive experience required
- Experience in the preparation of the submission of clinical modules in eCTD format required.
- Familiarity with organizing responses to Health Authority information requests required.
- 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 work with firm deadlines and adapt quickly to changing requirements and priorities
- Strong organizational skills, written and oral communication skills, and attention to detail
- Ability to successfully manage multiple changing deadlines and operate in ambiguity
Nice To Haves
- Familiarity with regulatory submissions outside of the US a bonus
Responsibilities
- Evaluate clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, data management plan, and any other clinical trial associated document
- Assemble the reporting of clinical studies sponsored by IBRX
- Draft and finalize documents for regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, briefing books, and any other application documents.
- Prepare responses to Health Authority comments and questions pertaining to clinical issues.
- Assist with version‑control governance by supervising a centralized document repository, applying naming‑convention standards, authorizing change‑tracking procedures, and assisting with final module versions prior to electronic upload to ensure audit‑ready documentation
- Provide guidance, training, and expert opinion to others in the preparation, analysis, and documentation of studies
- Monitor and analyze emerging Health‑Authority guidance to anticipate regulatory shifts and advise cross‑functional teams.
- Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
Benefits
- Medical, Dental and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, 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 and Employee Discounts, Rewards and Perks
- Paid Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
- This position is eligible for a discretionary bonus and equity award.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Principal
Number of Employees
251-500 employees
