Regulatory Specialist

Location

NYC (Must be willing to commute daily to new state‑of‑the‑art research center in the Hub in South Bronx nearby public transportation)

• Competitive Salary, Rapidly Growing Company.
• Candidate needs previous experience as a Clinical Trial Regulatory Specialist in pharma‑sponsored interventional studies.
• Ideal candidate would be willing to work in a fast‑moving, dynamic, fun, patient‑centered environment and be a self‑starter and lifelong learner.
• Must already be located in NYC Area.

Regulatory/Quality Assurance Manager

The Regulatory Specialist will play a crucial role in supporting the regulatory affairs team to ensure compliance with all applicable regulatory requirements for clinical research projects. You will work closely with the Regulatory/Quality Assurance Manager and collaborate with teams across locations to maintain compliance with regulatory guidelines. This role will involve preparing and submitting regulatory documents, tracking regulatory deadlines, maintaining up‑to‑date records, monitoring changes in regulatory policies, and supporting regulatory submissions for marketing ads.

• Regulatory Support: Assist the regulatory affairs team in ensuring compliance with all applicable regulatory requirements for clinical research projects.
• Document Preparation & Submission: Assist with the preparation, submission, and tracking of regulatory documents, and maintain up‑to‑date records and files for clinical trials.
• Regulatory Filings: Prepare and submit regulatory documents to authorities (e.g., IRB, FDA), track deadlines, and manage submissions to ensure timely compliance.
• Regulatory File Management: Maintain and organize regulatory files, including study‑specific documents, informed consent forms, and investigator brochures.
• Compliance Monitoring: Monitor regulatory updates and changes in guidelines to ensure compliance with local, state, and federal regulations.
• Coordination with Sponsors & Teams: Coordinate with study sponsors and internal teams to ensure regulatory documents are complete, accurate, and submitted on time.
• Regulatory Correspondence: Support regulatory correspondence with study sponsors and agencies, including responses to inquiries.
• Audit & Inspection Support: Assist with regulatory audits and inspections as required, ensuring documents are in order and facilitating the process when audits occur.
• Additional Duties: Perform other duties as assigned.

If interested, please reach out to gulerio@equity‑ with your CV and outline why you are a good fit for the role including past relevant experience. Please do not apply if you are not already located in the greater NYC area and can commute to our location. Thank you.

Equity Medical, LLC (“EM