Regulatory Specialist (Clinical Research) Position Available In Miami-Dade, Florida

Regulatory Specialist (Clinical Research) Biogenix Molecular Miami, FL 33165 Job Summary We are seeking a detail-oriented ,knowledgeable and experience Regulatory Specialist to join our team. The ideal candidate will play a crucial role in ensuring compliance with FDA regulations and managing all the regulatory aspects of clinical trials. This position involves working closely with cross-functional teams to support research initiatives and maintain high standards of quality assurance within the organization. Candidate must have experience with Real-Time CTMS and

CENTRAL IRBS. IN PERSON ONLY NO RECOLATION /NO REMOTE CANDIDATES. MUST HAVE KNOWLEDGE OF CTMS REAL TIME.

Duties Develop and implement regulatory strategies to ensure compliance with FDA regulations and guidelines. Prepare, review, and submit regulatory documents for clinical trials, including Investigational New Drug (IND) applications. IRB submission to ADVARRA and WCG Collaborate with project management teams to ensure timely completion of regulatory submissions and adherence to project timelines. Monitor changes in regulations and assess their impact on ongoing projects; provide guidance to internal teams as necessary. Assist in the development of quality assurance processes to ensure compliance with industry standards. Maintain comprehensive records of all regulatory submissions, communications, and approvals for audit purposes.

ISF/ TMF / IRB

Requirements Bachelor’s degree in a relevant field such as Life Sciences, Chemistry, or Regulatory Affairs; advanced degree preferred. Proven experience in regulatory affairs, particularly within clinical trials or pharmaceutical settings. Strong understanding of FDA regulations and compliance management practices. Excellent project management skills with the ability to manage multiple tasks simultaneously while meeting deadlines. Familiarity with quality assurance principles and practices is highly desirable. Exceptional research skills and attention to detail are essential for success in this role. Strong communication skills, both written and verbal, to effectively collaborate with internal teams and external stakeholders. Completion of 1572s, Training Logs, DOA Logs, Experince with PSV And SIV visits Timely Completion of Initial Regulatory packages as submitted by Sponsor. GCP Certified. Strong Background in EDC/ EMR and computer skills.

Job Type:

Full-time Pay:

$70,000.00 – $89,341.00 per year

Benefits:

Health insurance

Schedule:

8 hour shift Ability to

Commute:

Miami, FL 33165 (Required)

Work Location:

In person