Regulatory Analyst - Remote
Miami, FL · On-site +1
Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough knowledge of federal regulations and University policies. * Oversees accurate and timely processing ...
Miami, FL · On-site +1
Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough knowledge of federal regulations and University policies. * Oversees accurate and timely processing ...
Miami, FL · On-site +1
Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough knowledge of federal regulations and University policies. * Oversees accurate and timely processing ...
Miami, FL · On-site +1
Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough knowledge of federal regulations and University policies. * Oversees accurate and timely processing ...
Miami, FL · On-site +1
Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough knowledge of federal regulations and University policies. * Oversees accurate and timely processing ...
Miami, FL · On-site +1
CORE JOB SUMMARY The Regulatory Analyst I prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure. CORE JOB ...
Miami, FL · On-site +1
CORE JOB SUMMARY The Regulatory Analyst I prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure. CORE JOB ...
Miami, FL · On-site +1
CORE JOB SUMMARY The Regulatory Analyst I prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure. CORE JOB ...
Miami, FL · On-site +1
CORE JOB SUMMARY The Regulatory Analyst I prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure. CORE JOB ...
Miami, FL · On-site +1
CORE JOB SUMMARY The Regulatory Analyst I prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure. CORE JOB ...
Miami, FL · On-site +1
CORE JOB SUMMARY The Regulatory Analyst I prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure. CORE JOB ...
Miami, FL · On-site +1
CORE JOB SUMMARY The Regulatory Analyst I prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure. CORE JOB ...
Miami, FL · On-site +1
CORE JOB SUMMARY The Regulatory Analyst I prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure. CORE JOB ...
Cape Coral, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Cape Coral, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Tampa, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Tampa, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Miami Gardens, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Miami Gardens, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Orlando, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Orlando, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Port Saint Lucie, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Port Saint Lucie, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Pembroke Pines, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Pembroke Pines, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Palm Bay, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Palm Bay, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Lakeland, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Lakeland, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Fort Myers, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Fort Myers, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Deltona, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Deltona, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Pompano Beach, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Pompano Beach, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Tallahassee, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Tallahassee, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Gainesville, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Gainesville, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Clearwater, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
Clearwater, FL · Remote
$50 - $70/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help ...
$30.3K - $36.9K
2% of jobs
$36.9K - $43.6K
7% of jobs
$43.6K - $50.2K
7% of jobs
$56K is the 25th percentile. Wages below this are outliers.
$50.2K - $56.9K
9% of jobs
$56.9K - $63.6K
12% of jobs
The median wage is $69K / yr.
$63.6K - $70.2K
15% of jobs
$70.2K - $76.9K
16% of jobs
$82.1K is the 75th percentile. Wages above this are outliers.
$76.9K - $83.5K
8% of jobs
$83.5K - $90.2K
11% of jobs
$90.2K - $96.8K
2% of jobs
$96.8K - $103.5K
11% of jobs
$30.3K
$71.3K
$103.5K
As a Remote Regulatory professional, your daily responsibilities generally include preparing and reviewing regulatory submissions, tracking deadlines, interpreting respective guidelines, and maintaining up-to-date records for compliance with local and international regulatory authorities. You’ll likely coordinate with product development, legal, and quality assurance teams to ensure all documentation and processes align with required standards. The role often involves ongoing research into regulatory changes and proactive problem-solving to address compliance issues. Remote work allows for flexible collaboration, but strong time management and communication skills are necessary to keep projects on track and stakeholders informed.
A Remote Regulatory job involves ensuring that a company complies with relevant laws, regulations, and industry standards while working from a remote location. Professionals in this field may handle regulatory filings, monitor compliance policies, and liaise with government agencies. These roles are common in industries such as healthcare, pharmaceuticals, finance, and telecommunications. Strong attention to detail, knowledge of regulatory frameworks, and effective communication skills are essential for success in this role.
To thrive as a Remote Regulatory professional, you need a solid understanding of regulatory frameworks, compliance standards, and relevant industry regulations, often supported by a degree in law, life sciences, or a related field. Familiarity with regulatory submission systems (such as FDA, EMA portals), document management tools, and relevant certifications like RAC (Regulatory Affairs Certification) are highly advantageous. Strong attention to detail, effective written communication, and the ability to work independently are essential soft skills. These competencies ensure accurate compliance documentation, effective cross-functional collaboration, and successful navigation of complex regulatory requirements in a remote environment.

Full-time
Medical, Dental
Re-posted 25 days ago
7.7
Based on 52 frontline employees who took The Breakroom Quiz
257th of 616 rated colleges and universities
Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet.
The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Regulatory Analyst 1 to work at the UHealth campus in Miami, Fl.
CORE JOB SUMMARY
The Regulatory Analyst 1 - UHealth conducts on-site audits and reviews consolidated records. The incumbent designs, reviews, and tests the revised treatment matrix to identify possible cancers from claims data.
CORE JOB FUNCTIONS
Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough knowledge of federal regulations and University policies.
Oversees accurate and timely processing, tracking, and filing of federally mandated submissions.
Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance.
Provides support to investigators by reviewing submissions for content.
Sends decision correspondence to appropriate parties, requesting information.
Maintains accurate databases and generates letters.
Develops and maintains templates, creates files, and mails notices.
Adheres to University and unit-level policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
Education: Bachelor's degree in relevant field required
Experience: Minimum 1 year of relevant experience required
Knowledge, Skills and Abilities:
Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
Teamwork: Ability to work collaboratively with others and contribute to a team environment.
Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.
Job duties will include, but not be limited to:
Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study start-up to study closure, including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors.
Completion of the new protocol submission packet with the information provided by PRMC as well as any additional required documentation (i.e., local protocol, HIPAA forms, etc.). Modifying and standardizing consent forms for IRB submission is required.
Compilation of documents in order to prepare the following forms for IRB submission to ensure protocol compliance with federal regulations. This process will take place from study start-up throughout the completion of the study.
Initial IRB application
Amendments / modifications
Reportable new information
Protocol deviations / violations
Protocol exceptions
IND safety letters
Continuing and final reports
Other communications from the sponsor requiring IRB submission.
Preparation and maintenance of regulatory binders (paper or electronic) with all necessary study documentation in compliance with institutional standard operating procedures (SOPs), sponsor requirements (as applicable) and applicable regulatory requirements.
Communication with study staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL). Ensure in conjunction with the DOAL that all protocol-related training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder.
Maintains department credentialing information and research records for clinical trials within institution's electronic systems (e.g., Velos, Complion) and appropriate drives, as applicable.
Participate in site visits with monitors as well as site audits concerning compliance of regulatory documents. Ensure timely resolution of observations identified during monitoring and auditing visits.
Communicate with Clinical Coordinators and PIs to review and submit protocol deviations and amendments as part of the plan to resolve the deficiencies identified during the audit/monitoring visit.
Assist in the collection and maintenance of credentialing information for study personnel (e.g., study-specific training, IBC, EHS requirements, etc.).
Upkeep of departmental trackers with study updates to ensure study team personnel are effectively alerted of initial study approvals and IRB approved study and consent amendments.
Communicate to SCCC staff and PI relevant aspects of the regulatory process concerning IRB approval of initial protocol, exceptions, continuing reports, and study modifications. This includes facilitation of training and notification of required re-consenting in collaboration with the clinical team following approval of study modifications.
Provides updates to the study team and/or management regarding submission statuses and approvals (e.g. initial and amendments) during internal team meetings and upon request.
Communicate with the sponsor and/or contract research organization for completion and submission of regulatory documents via inter-links, regular mail, or email as well as provide submission updates upon request. This responsibility is sponsor dependent. The following documents may be included:
Financial Disclosure Forms
FDA 1572
Initial Protocol Signature Page
Amendments signature page
Investigators CV and Medical Licenses
Laboratories normal ranges and certifications
IRB approvals
Approved consents
Other documents as required by the sponsor
Provide feedback to Regulatory Management on opportunities for regulatory process improvement.
Identifies and escalates issues before they become critical.
Assists with various regulatory related projects under the direction of the Regulatory Manager and/or Director of Regulatory.
Other duties as assigned by senior management.
Education:
Bachelor's degree required
Any relevant education, certifications and/or work experience may be considered.
Experience:
Minimum one (1) year of relevant experience in compliance, research, or a medical setting.
Experience in clinical trials is preferred.
#LI-YC1
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Job Status:
Full timeEmployee Type:
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The University of Miami, located in the beautiful Coral Gables, Florida, is a comprehensive, private research institution in the United States. Operating within the higher education industry, the institution offers a multitude of degree programs spanning over 180 majors and program through its 12 colleges. The University was founded in 1925 with the mission to disseminate knowledge, transform lives, and change the world - a mission it has held faithfully to this day. Notably, the University of Miami has gained global recognition for its commitment to research and innovation, with over $324 million in research and sponsored project funding awarded annually.
Colleges, universities, and professional schools
10,000+ Employees
Coral Gables, FL, US
1925