Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Regulatory Analyst I assisting in regulatory processes for clinical research studies at USF. Supporting IRB submissions and compliance tracking across multiple systems with a focus on Good Clinical Practice.
Responsibilities
- Assist with the preparation and submission of IRB applications, amendments, continuing reviews, and closures.
- Upload and organize regulatory documents in Florence eBinders (eISF) following institutional SOPs and version control requirements.
- Maintain tracking logs for training, delegation, protocol versions, and other required regulatory documentation.
- Enter and update study-related regulatory activity in Velos (CTMS) to support documentation and billing.
- Ensure study team credentialing and training documentation are accurate and current.
- Assist with audit readiness and inspection preparation by maintaining organized and compliant eBinders.
- Support communication with IRBs, sponsors, and internal stakeholders regarding documentation and updates.
- Ensure protection of confidential data in accordance with HIPAA and institutional standards.
- Participate in team trainings, internal process reviews, and quality improvement efforts.
- Perform other duties as assigned by supervisor or leadership.
Requirements
- Associate’s degree in a scientific, health-related, or business field, OR equivalent combination of education and relevant experience.
- One year of experience in a healthcare, academic, administrative, or research setting.
- Experience with Microsoft Office (Word, Excel, Outlook) required.
- Experience in research administration, IRB submission, or regulatory documentation (preferred).
- Familiarity with Florence eBinders, Velos CTMS, or other regulatory platforms (preferred).
- Understanding of clinical research protections, HIPAA, and GCP guidelines (preferred).
Benefits
- medical, dental and life insurance plans
- retirement plan options
- employee and dependent tuition programs
- generous leave
- hundreds of employee perks and discounts
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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