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Actalent ยท 2 days ago
Regulatory Specialist
Indianapolis, IN
Full-time
Onsite
Mid Level
3+ years exp
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Responsibilities
Responsible for submission of research protocols and other required documents/components to the FDA for investigational new drug (IND)/investigational device exemption (IDE) or biologics applications.
Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities.
Provides technical review and report preparation and submission of FDA required reports of ongoing sponsored and held IND/IDE applications.
Coordinates regulatory processes and submissions for multi-site research.
Responsible for preparing and submitting new research protocols, protocol amendments, continuing reviews, other study modifications, investigational product updates (investigational brochures and/or device manuals) and ensuring completeness and accuracy of documents while meeting all applicable submission deadlines.
Responsible for preparing and submitting new informed consent documents, revisions to the informed consent, including any required financial disclosure language, and communicating when IRB requires re-consenting of enrolled subjects. Also ensuring all languages of the informed consent requested by the study team are reviewed and approved.
Qualification
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Required
3+ years of Clinical Research Regulatory experience REQUIRED
Preferred
Oncology experience preferred
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
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
Company data provided by crunchbase
