Regulatory Affairs Specialist ensuring compliance for all Hershey ingredients and finished products. Involves monitoring global food regulations and executing product labeling compliance.
About the role
- Regulatory Specialist III supporting clinical trials and managing regulatory affairs and compliance at Emory University. Liaison between sponsors, investigators, and regulatory entities.
Responsibilities
- The Regulatory Specialist III is an advanced level position supporting regulatory affairs in clinical trials research.
- Support all trial complexities (basic to multiphase) and manage the study activation process.
- Serve as the internal project manager for assigned specific oncology disease group(s).
- Liaison between the sponsor, the investigator, Winship, Emory IRBs, external IRBs and internal departments/staff.
- Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
- Prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
- Responsible for 35+ trial load per year of NCTN, industry and investigator-initiated trials.
- Maintain study regulatory binders and electronic files in accordance with institutional and sponsor requirements.
- Coordinate protocol activation/maintenance process and communicate to allow for enrollment to start.
- Disseminate information and coordinate or conduct training.
Requirements
- Typically requires a Master's degree and several years of experience in clinical research, with a focus on regulatory affairs.
- Strong knowledge of federal regulations, IRB processes, and relevant guidelines (e.g., ICH/GCP) is essential.
- Excellent verbal and written communication skills are required for interacting with various stakeholders.
- A high level of accuracy and attention to detail is critical for managing complex documentation.
- Must be highly organized and able to manage a large workload, often involving multiple trials.
- Strong computer skills, including experience with clinical trial management systems and standard office software, are necessary.
- Bachelor's degree and five years of experience in a research environment, or an equivalent combination of experience, education and training.
- Must obtain all required training courses within one month of hiring date.
- Must possess an applicable research certification within 2 years of hire (i.e. ACRP, SOCRA, RAC etc.).
Benefits
- Health and Safety Information
- Remote Work Classification Hybrid
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Tech skills
Location requirements
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