Regulatory Relations Liaison jobs in Daytona Beach, FL

Job Description:
We are seeking a highly organized and detail-oriented part-time Regulatory Specialist to join our team. The Regulatory Specialist will be responsible for managing all aspects of regulatory affairs for our clinical research site, ensuring compliance with regulatory requirements, and facilitating communication with regulatory authorities.

Responsibilities:

• Prepare and submit regulatory documents, including IRB submissions, IND/IDE applications, and regulatory reports.
• Monitor regulatory changes and update internal processes and procedures accordingly.
• Maintain accurate and up-to-date regulatory documentation and records.
• Collaborate with cross-functional teams to ensure regulatory compliance throughout the research process.
• Serve as the primary point of contact for regulatory inquiries and audits.

Qualifications:

• Bachelor's degree in a related field (e.g., life sciences, regulatory affairs).
• Minimum of 3 years of experience in regulatory affairs within the pharmaceutical, biotechnology, or clinical research industry.
• Knowledge of FDA regulations, Good Clinical Practice (GCP), and other relevant regulatory guidelines.
• Strong attention to detail and excellent communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications:

• Certification in Regulatory Affairs (e.g., RAC) is a plus.
• Experience with regulatory submissions for clinical trials is highly desirable.
• Experience as a Clinical Research Coordinator is advantageous
• Familiarity with electronic document management systems is advantageous.

Job Type: Part-time

Pay: $40,000.00 - $55,000.00 per year

Expected hours: 30 per week

Experience level:

• 3 years

Schedule:

• 8 hour shift

Ability to Relocate:

• Orange City, FL 32763: Relocate before starting work (Required)

Work Location: In person