Clinical Trial Regulatory Specialist

Equity Medical; Mississauga; Hybrid; CAD 60,000 - 100,000; Full time

Job summary

A leading clinical trial research company is seeking a Clinical Trial Regulatory Specialist. This position involves supporting regulatory affairs by ensuring compliance with applicable guidelines, preparing regulatory documents, and collaborating with internal teams across various locations. The ideal candidate should have previous experience in clinical trials and be adaptable in a fast-paced and patient-focused environment.

Qualifications

• Previous experience as a Clinical Trial Regulatory Specialist in pharma-sponsored interventional studies.
• Self-starter and lifelong learner.
• Willingness to work in a fast-moving, dynamic, patient-centered environment.

Responsibilities

• Ensure compliance with all regulatory requirements for clinical research.
• Prepare and submit regulatory documents to authorities such as IRB and FDA.
• Maintain and organize regulatory files and track submission deadlines.

Skills

Regulatory Compliance

Document Preparation

Audit Support

Education

Bachelor's Degree in Life Sciences

Job description

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Key Points: 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 would be a self-starter and lifelong learner.

Reports To: Chief Quality Assurance Officer

Employment Type: Full-time Hybrid (Remote with ~once weekly Onsite Requirement in Bowling Green Office)

Job Overview:

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.

Job Description:

1. Regulatory Support

As a Regulatory Specialist, you will play a key role in supporting the regulatory affairs team to

ensure compliance with all applicable regulatory requirements for clinical research projects.

2. Document Preparation & Submission

You will assist with the preparation, submission, and tracking of regulatory documents, as well

as maintaining up-to-date records and files for clinical trials.

You will report directly to the Regulatory / Quality Assurance Manager and collaborate with

both the New York and Kentucky teams to ensure efficient and compliant regulatory processes.

4. Regulatory Filings

Key responsibilities will include preparing and submitting regulatory documents to authorities

(e.g., IRB, FDA), tracking deadlines, and managing submissions to ensure timely compliance.

5. Regulatory File Management

Maintain and organize regulatory files, including study-specific documents, informed consent

forms, and investigator brochures.

6. Compliance Monitoring

Monitor regulatory updates and changes in guidelines to ensure compliance with local, state,

and federal regulations.

7. Coordination with Sponsors & Teams

Coordinate with study sponsors and internal teams to ensure regulatory documents are

complete, accurate, and submitted on time.

8. Regulatory Correspondence

Support regulatory correspondence with study sponsors and agencies, including responses to

inquiries.

9. Audit & Inspection Support

Assist with regulatory audits and inspections as required, ensuring documents are in order and

facilitating the process when audits occur.

10. Additional Duties

Perform other duties as assigned.

If interested, please reach out to [e-mail] with your CV and outlining why you are a good fit for the role. Thank you.

About Equity Medical

Equity Medical, LLC (“EM") is a multi-state, multi-therapeutic area clinical trial research company specializing in the dermatology and allergy/immunology/respiratory therapeutic areas. Founded by board-certified dermatologists Dr Michael Cameron and Dr James Allred, EM has dedicated research centers with board-certified dermatologists, allergists/immunologists, and internists in New York City, Nashville, and Bowling Green. EM is committed to excellence in diversity and the creation of an inclusive learning and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Hospitals and Health Care

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