Principal Specialist, Health Authorities
immunitybioSummit, NJ
Principal Specialist, Health Authorities
immunitybioSummit, NJLead L6
Biological Product ManufacturingResearch and Development in BiotechnologyIn-Vitro Diagnostic Substance Manufacturing
APPLY NOW (opens in a new tab)Principal Specialist, Health Authorities 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.
Essential Functions:
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 IBRXDraft 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.
Education & Experience:
- Bachelor's Degree in life sciences or technical discipline with 10+ years of relevant progressive experience required; orMaster'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.
- Familiarity with regulatory submissions outside of the US a bonus
- Knowledge, Skills, & Abilities
- 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
- Working Environment / Physical Environment
- This position works on site in Summit, NJ. as noted in the offer letter.
- Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
- This position may need to sit for long periods of time and use various computer programs.
- This desk-based role involves the close study of scientific and regulatory documents.
- This position will work closely with scientific colleagues throughout the day, often on a project team basis.
This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.$164,000 (entry-level qualifications) to $180,000 (highly experienced) annually
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
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Level
Lead L6
Location
Summit, NJ
Occupation
Regulatory Affairs Managers
Industry
Biological Product Manufacturing
Posted
7 days ago