SCCP_ Regulatory Specialist _Fall 2026
About The Position
The Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel Deaconess Medical Center (BIDMC), within the Sadhguru Center for a Conscious Planet and BIDMC Anesthesia. This role leads regulatory oversight and documentation management across a clinical research portfolio, including multiple active studies and large multisite trials. The specialist is the primary regulatory point of contact, working with the IRB, sponsors, investigators, and internal study teams to maintain compliance throughout the research lifecycle and help activate studies for patient enrollment. The role also supports regulatory processes for industry, cooperative-group, and investigator-initiated studies; manages submissions and study documentation; helps develop and implement regulatory SOPs; and contributes to workflow improvement and staff training. The Regulatory Specialist serves as a subject matter expert for audits and supports regulatory and quality compliance.
Requirements
- Bachelor's degree in a life sciences, healthcare, or related field; a bachelor's degree is required.
- 1–3 years of related work experience.
- Good understanding of FDA, cooperative group, NCI, and OHRP regulatory guidelines.
- Strong working knowledge of ICH-GCP guidelines and IRB submission processes.
- Experience organizing clinical trial documents in Trial Master File format.
- Experience with computer systems, including web-based applications and Microsoft Office applications such as Outlook, Word, Excel, PowerPoint, or Access.
- Ability to maintain confidential and sensitive information, set priorities, and work independently and collaboratively with research and hospital personnel.
- Strong written and oral communication skills in English.
- Strong organizational skills and attention to detail.
- Ability to manage priorities and multitask.
- Ability to work collaboratively in small teams, offer ideas, identify issues, and respect team members.
- Ability to provide professional, respectful, service-oriented customer service and remain calm in stressful situations.
Nice To Haves
- Master's degree, preferably in Regulatory Affairs.
- 1–3 years of clinical trial regulatory affairs experience.
- Experience managing Microsoft platforms, especially SharePoint.
Responsibilities
- Prepare and submit new research applications for industry, cooperative-group, and investigator-initiated studies, respond to IRB comments, and work with study teams to activate studies for patient enrollment.
- Prepare and assist with submissions for protocol amendments, IND safety reports, ADEERS submissions, consent form changes, continuing reviews, violations, and protocol deviations.
- Oversee reporting of adverse events, serious adverse events, IND safety data, violations, and deviations, and submit other study documents needed to support regulatory compliance.
- Troubleshoot regulatory processes and procedures when issues are identified.
- Assist investigators and study teams with preparing and submitting IND applications to the FDA.
- Prepare and submit annual reports to the FDA and submit regulatory documents to NIH/OBA and local biosafety committees for oncology human gene transfer trials.
- Act as a liaison between the IRB and investigators to resolve regulatory queries and concerns.
- Maintain regulatory binders and clinical study folders in Florence and SharePoint.
- Assist with preparing and implementing regulatory office SOPs.
- Provide regulatory oversight and documentation management for new and ongoing clinical studies.
- Serve as a subject matter expert for internal and external audits and maintain regulatory and quality compliance standards.
- Establish and continuously improve regulatory workflows and processes.
- Deliver training on regulatory requirements to internal staff and study teams.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
