Regulatory Specialist Position Available In Miami-Dade, Florida

Regulatory Specialist Biogenix Molecular Miami, FL Job Details Full-time $55,000

• $75,000 a year 8 hours ago Benefits 401(k) Qualifications Biotechnology Clinical research English Research Mid-level Analysis skills Compliance management Project management Quality assurance Bachelor’s degree Product development Clinical trials 2 years Communication skills FDA regulations Under 1 year Full Job Description Job Summary We are seeking a detail-oriented and knowledgeable Regulatory Specialist to join our team.

The ideal candidate will play a crucial role in ensuring compliance with FDA regulations and other regulatory requirements. This position involves working closely with various departments to support clinical trials, manage compliance processes, and contribute to the quality assurance of our products. The Regulatory Specialist will be instrumental in maintaining the integrity of our research and development efforts while ensuring adherence to industry standards. The Regulatory Specialist

MUST HAVE CLINICAL RESEARCH EXPERIENCE

in DADE COUNTY and

HAVE USE REAL-TIME CTMS. PLEASE DO NOT APPLY IF YOU DO NOT HAVE EXPERIENCE WITH

COMPUTERS and

CTMS SOFTWARE

(REALTIME) Responsibilities

• Develop and maintain regulatory strategies for chemistry manufacturing controls, ensuring alignment with FDA regulations.
• Manage compliance documentation and submissions for clinical trials, including Investigational New Drug (IND) applications.
• Collaborate with cross-functional teams to ensure that all research activities comply with regulatory standards.
• Conduct regular audits and assessments to ensure adherence to quality assurance protocols.
• Prepare and submit regulatory filings, including reports and updates as required by governing bodies.
• Monitor changes in regulations and industry standards, providing guidance on necessary adjustments to internal processes.
• Assist in project management activities related to regulatory submissions and compliance initiatives.
• Complete Regulatory PACKETS in a timely BASIS as directed by

SPONSORS

• Budgeting /CTA audit. Requirements
• Bachelor’s degree in a relevant field such as life sciences, chemistry, or regulatory affairs.
• Proven experience in regulatory compliance management within the pharmaceutical or biotechnology industries.
• Strong understanding of FDA regulations and guidelines related to clinical trials and product development. Knowledge pf CFR 21 is a MUST.
• Experience in quality assurance processes and methodologies.
• Excellent project management skills with the ability to handle multiple tasks simultaneously.
• Strong analytical skills with attention to detail and problem-solving capabilities.
• Effective communication skills, both written and verbal, for collaboration across departments.
• Previous experience in research or clinical trial environments is a plus.
• Experience with REAL
• TIME software system

• MUST HAVE EXPERIENCE IN IRB SUBMISSION/ TRIAL START-UP DOCUMENTATION

• MUST SPEAK , UNDERSTAND and

WRITE ENGLISH

We invite qualified candidates who are passionate about regulatory affairs and committed to maintaining high standards of compliance to apply for this exciting opportunity.

Job Type:

Full-time Pay:

$55,000.00

• $75,000.

00 per year

Benefits:

401(k)

Schedule:

8 hour shift Ability to

Commute:

Miami, FL 33165 (Required) Ability to

Relocate:

Miami, FL 33165: Relocate before starting work (Required)

Work Location:

In person