Regulatory Specialist

Beth Israel Deaconess Medical Center's Cancer Clinical Trials Office supports clinical research across multiple cancer disease programs. The Regulatory Specialist prepares and submits regulatory applications and documents, supports FDA and IRB submissions, oversees regulatory reporting, and helps ensure compliance for oncology clinical trials.

Responsibilities

Prepare and submit applications, including preparation of consent forms to the DFHCC IRB on all cancer center clinical trials (industry, cooperative groups and PI initiated studies), and respond to IRB comments on applications submitted and work with study team in getting studies activated for enrollment of patients

Prepare and assist in submission of protocol amendments, IND safety reports, ADEERS submission, consent form changes, continuing reviews, violations and deviations to study protocols.Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance, and troubleshoots processes and procedures when issues are identified

Assist investigators and study teams in preparing and submitting IND applications to the FDA. Preparation and submission of annual reports to the FDA. Submission of regulatory documents to NIH/OBA, local bio safety committees on oncology human gene transfer trials

Act as a liaison between the DFHCC IRB and investigator to resolve regulatory queries and concerns

Assist in the preparation and implementation of regulatory office SOPs

Preferred

Master's degree preferred in Regulatory Affairs

Five years equivalent experience in a clinical research and regulatory environment

Five years equivalent experience in a clinical research and regulatory environment.

Master's degree in Regulatory Affairs

Clinical research experience

Regulatory environment experience

Company

Integrated health care system providing patient care, research, education

Cambridge, Massachusetts, USA

https://www.bilh.org/

Founded in 2019

10001+ employees

Qualifications

Bachelor's degree required in Life Science or related field

1-3 years related work experience required

One - three years of previous clinical trial regulatory affairs experience

Must demonstrate good understanding of FDA, cooperative group, NCI and OHRP regulatory guidelines

Must maintain confidential and sensitive information, set own priorities, and work both independently and collaboratively with other research and hospital personnel

Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access

Ability to communicate clearly and effectively in written English with internal and external customers

Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers

Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations

Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members

Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving

Ability to remain calm in stressful situations

Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally

Master's degree preferred in Regulatory Affairs

Five years equivalent experience in a clinical research and regulatory environment

1-3 years related work experience required.

One - three years of previous clinical trial regulatory affairs experience.

Required skills

Clinical Trial Regulatory Affairs, FDA Regulatory Guidelines, Cooperative Group Regulatory Guidelines, NCI Regulatory Guidelines, OHRP Regulatory Guidelines, Microsoft Office

Preferred skills

Master's degree preferred in Regulatory Affairs, Glassdoor, 3.5, Cambridge, Massachusetts, USA, https://www.bilh.org, Late Stage, Leadership Team, Avery Palardy, Executive Director, Climate & Sustainability, Robert Fields, EVP, Chief Clinical Officer, Recent News, Boston Globe, 2026-10-09, Seattle TechFlash, 2026-10-08, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances, Build Cover Letter, Make your application stand out, Analyze How Well You Fit, Understand your strength & weakness

Experience

1-3 years