Top 86 Regulatory affairs Jobs in Florida

Regulatory Coordinator
CenExel Clinical Research —Hollywood, FL
- Overtime
- Background check
- Microsoft Excel
- Psychiatry
- Health savings account
- Health insurance
Quick Apply
Research Regulatory Affairs Specialist I
Florida Cancer Specialists & Research Institute —West Palm Beach, FL
- Full-time
- Background check
- Microsoft Outlook
- Customer service
- Tuition reimbursement
- 401(k) matching
Research Regulatory Affairs Speciallist
Florida Cancer Specialists & Research Institute —Fort Myers, FL
- Full-time
- Background check
- Microsoft Outlook
- Customer service
- Tuition reimbursement
- 401(k) matching
Regulatory Affairs
5TH HQ LLC —Plantation, FL
- $19 - $20 an hour
- Microsoft Excel
- Mid-level
- Bachelor's degree
Regulatory Analyst 1
University of Miami —Miami, FL
- Full-time
- Remote
- HIPAA
- Bachelor's degree
- Organizational skills
- Health insurance
- Dental insurance
Regulatory Affairs Coordinator
ZimVie Inc. —Palm Beach Gardens, FL
- Microsoft Excel
- Microsoft Outlook
- Computer literacy
Regulatory Affairs Specialist
Dentsply Sirona —Sarasota, FL
- Online Application
- Mid-level
- Office
- Databases
Regulatory Affairs Associate
US ARKRAY INC —Doral, FL
- Full-time
- Microsoft Excel
- OSHA
- Mid-level
Quick Apply
Personal Care Regulatory and R&D Manager
Restem Group Inc. / thebiobox LLC —Miami, FL
- $73,500 - $75,000 a year
- Full-time
- Background check
- 5 years
- Bachelor's degree
- Health savings account
- Health insurance
Quick Apply
10d
Manager, Regulatory Affairs
ADMA Biologics —Boca Raton, FL
- Full-time
- 5 years
- Office
- Master's degree
- Paid holidays
- Disability insurance
Quality Assurance Compliance Coordinator
Monin Gourmet Flavorings —Clearwater, FL
- Pass drug screening
- Mid-level
- Continuous improvement
- Paid holidays
- Health insurance
Quick Apply
Senior Manager, Regulatory Affairs
ADMA Biologics —Boca Raton, FL
- Full-time
- Office
- Bachelor's degree
- Team management
- Paid holidays
- Disability insurance
Sr Director Regulatory Affairs
Tampa Electric Company —Tampa, FL
- 8 hour shift
- Office
- Finance
- Travel
- Paid holidays
- Dental insurance
Paralegal - Licensing & Regulatory Compliance
BPI labs (Belcher Pharmaceuticals LLC) —Largo, FL
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Senior Director, Regulatory Affairs (Inhalations – ANDAs and 505 (b)(2))
Lupin Pharmaceuticals Inc. —Coral Springs, FL
- Full-time
- English
- Office
- Doctor of Philosophy
Global Regulatory Compliance Specialist
Life Extension Foundation Buyers Club Inc —Fort Lauderdale, FL
- Full-time
- Mid-level
- Bachelor's degree
- Organizational skills
Quick Apply
3d
Principal Regulatory Compliance Analyst
NextEra Energy, Inc. —Jupiter, FL
- Full-time
- 5 years
- Office
- Analysis skills
Principal Regulatory Investigation Analyst
NextEra Energy, Inc. —Jupiter, FL
- Full-time
- 7 years
- High school
- Office
Sr. Research Regulatory Specialist (Full Time, Days)
Nicklaus Children's Hospital —Miami, FL
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Bachelor's degree
State Filing Lead Analyst - Cigna Healthcare - Hybrid
The Cigna Group —Tampa, FL
- Online Application
- Customer service
- Research
- Mid-level

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Regulatory Coordinator

CenExel Clinical Research -
Hollywood, FL

Quick Apply

Job Details

Full-time

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Flexible spending account
Vision insurance
401(k) matching
Life insurance

Qualifications

Computer operation
Microsoft Excel
Clinical research
Word processing
Writing skills
Drug regulation
High school diploma or GED
Regulatory affairs
Typing

Full Job Description

About Us:

Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Job Summary:

With moderate oversight the Regulatory Coordinator I is responsible for the preparation, organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs. Maintain regulatory documents in accordance with applicable regulations and coordinate required investigator and study staff training.

Essential Responsibilities and Duties:

Collects, prepares, and submits documentation to various sponsors/CROs during study start-up, including:
o Submission documents/approvals
o Protocol amendments with respective signature pages
o Informed consent documents
o FDA form 1572
o Lab normal result documents
o financial disclosure forms
o Delegation of authority logs
o Licenses
o Reports
o Logs (e.g., temperature logs, drug accountability logs, master subject logs, screening and enrollment logs, specimen logs, etc.)
Collects, prepares, and submits documentation to institutional review boards for all ongoing and new trials.
Serve as a liaison between the IRB, site, and investigator.
Obtain necessary signatures from investigators and staff.
Maintains and tracks current staff credentials (i.e., CV, certifications, etc.)
Maintains and distributes new and revised regulatory documents to applicable site staff and applicable corporate teams.
Refers necessary regulatory questions to Sr. Regulatory Coordinator, Regulatory Manager or Regional Regulatory Manager.
Maintains regulatory documents for ongoing trials, and ensures all appropriate regulatory documents are archived at the conclusion of the study.
Submits applicable subject facing documents for translations.
Maintains current Clinical Conductor Regulatory information.
Prepares appropriate reports for submission as required to the IRB including Serious Adverse Events (SAE’s), protocol deviations and other required reports.
Completes onboarding of new Investigators, including CV creation, obtaining medical license, and training documents.
Ensures the regulatory binder is ready for monitor review during monitor visits. Meets with monitor, as necessary.
Assists with regulatory inspections and sponsor audits as necessary.
Performs close-out duties including preparing the final report to the IRB and ensuring all original documents are filed in the regulatory binder. Ensures all appropriate regulatory documents are archived at the conclusion of the study.
Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Education/Experience/Skills:

Must be a high school graduate or have GED equivalency.
0-2 years of experience in clinical research regulatory affairs.
Demonstrated prioritization and organizational skills to efficiently and effectively, providing accurate information in a timely manner.
Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs.
Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.
Ability to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner.
Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately.
Ability to learn and become proficient in eRegulatory systems, IRB portals, vendor portals and sponsor portals.
A critical thinker with strong attention to detail and superb problem-solving abilities.
Must be able to effectively communicate verbally and in writing.

Working Conditions

Indoor, Office environment.
Essential physical requirements include sitting, typing, standing, and walking.
Lightly active position, occasional lifting of up to 20 pounds.
Reporting to work, as scheduled, is essential.
Ability to work overtime, weekends, and/or holidays as needed.
Ability to travel as needed.

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Benefits:

401(k) matching
Dental insurance
Flexible spending account
Health insurance
Health savings account
Life insurance
Vision insurance

Experience:

Clinical research: 1 year (Required)
Regulatory : 1 year (Required)

Work Location: In person

Quick Apply

Refine Your Search

regulatory affairs jobs in florida

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Paralegal - Licensing & Regulatory Compliance

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Principal Regulatory Compliance Analyst

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Sr. Research Regulatory Specialist (Full Time, Days)

State Filing Lead Analyst - Cigna Healthcare - Hybrid

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