Actalent · 2 days ago
Certified Regulatory Specialist III
Houston, TX
Full-time
Remote
Mid Level
4+ years exp
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Responsibilities
Assist with the submission of research protocols and other required documents/components to the FDA for investigational new drug (IND)/investigational device exemption (IDE) or biologics applications.
Provide data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities.
Assist with technical review and report preparation and submission of FDA required reports for ongoing sponsored and held IND/IDE applications.
Coordinate regulatory processes and submissions for multi-site research.
Assist the Research Regulatory Manager in the orientation of new Research Regulatory Specialists.
Prepare and submit new research protocols, protocol amendments, continuing reviews, other study modifications, investigational product updates, and ensure the completeness and accuracy of documents while meeting submission deadlines.
Prepare and submit new informed consent documents, revisions to the informed consent, and communicate when IRB requires re-consenting of enrolled subjects. Ensure all languages of the informed consent requested by the study team are reviewed and approved.
Ensure all regulatory documents, including Essential Documents as defined by ICH/GCP guidelines, are in compliance with Federal regulations, ICH/GCP guidelines, AAHRPP standards, and all applicable policies and procedures.
Monitor all required review, approval, and clearance activities for each research protocol, maintaining detailed, complete, accurate, and current records.
Maintain regulatory documents by creating electronic folders in the eRegulatory application, filing them electronically, following standard file name criteria, and keeping all documents current per SOP and Federal, State, and IRB requirements.
Qualification
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Required
Must be SOCRA or ACRP certified
4+ years regulatory experience
Oncology experience
Quality assurance
Regulatory documents
Regulatory compliance
Regulatory submission
Start-up, maintenance, and close-out of studies
Documented experience in submitting and maintaining regulatory documents including research essential regulatory documents, conflicts of interest, and financial conflicts of interest
MUST HOLD active certification through a professional research organization such as SOCRA, ACRP, SRA, or PRIM&R
Preferred
Bachelor’s degree in healthcare related field or biological sciences and at least 3 years of work experience in a Regulatory research role
Benefits
Diversity, Equity & Inclusion
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Company
Actalent
Actalent is an engineering and sciences service company.
5,001-10,000 employees
H1B Sponsorship
Actalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (31)
2022 (63)
2021 (20)
Funding
Current Stage
Late StageLeadership Team
Scott Anderson
Chief Financial Officer
Alison Deming Bucek, SPHR, SHRM-SCP
Human Resource Business Partner
Recent News
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