Senior Specialist, Regulatory Operations
New
C
Care AccessClinical Research
Remote within the United States or Canada.Full-TimeSenior
Salary90,000 - 100,000 USD per year
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Job Details
- Experience
- Minimum of 4 years of experience
- Required Skills
- Microsoft Excel
Requirements
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
- Minimum of 4 years of experience in operational regulatory affairs within a research site, CRO, or pharmaceutical industry.
- Strong understanding of U.S. regulations and ICH GCP guidelines related to site operations.
- Proven ability to manage IRB submissions, regulatory document preparation, and ongoing compliance.
- Experience with electronic Investigator Site File (eISF) systems such as Florence or CRIO.
- Strong proficiency with clinical trials databases, MS Word, and Excel.
- Excellent verbal and written communication skills for cross-functional collaboration.
- Demonstrated ability to handle multiple tasks in a fast-paced environment with competing priorities.
- Experience managing FDA interactions and regulatory inspections.
- Strong strategic planning, risk management, and change management skills.
Responsibilities
- Provide regulatory advice, lead, execute and deliver regulatory project work.
- Support regulatory compliance activities for clinical research sites, ensuring adherence to FDA, OHRP and global regulatory standards.
- Coordinate and perform IRB site level submissions and maintenance of approvals throughout the study life cycle.
- Oversee regulatory documentation, tracking, and reporting processes to maintain compliance and readiness for inspections and audits.
- Ensure timely filing of safety reports, deviations, and amendments as per study requirements.
- Monitor and interpret changes in U.S. regulatory policies and guidelines, advising stakeholders on potential impacts.
- Support the development, review, and maintenance of departmental Standard Operating Procedures (SOPs), work instructions, and forms.
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