Regulatory Affairs Assistant Position Available In Guilford, North Carolina
Tallo's Job Summary: Regulatory Affairs Assistant at PulmonIx in Greensboro, NC. Responsibilities include preparing and submitting regulatory documents, supporting clinical trials, conducting research on regulatory requirements, and ensuring project timelines are met. Qualifications include a Bachelor's degree in Life Sciences or related field, strong FDA regulation knowledge, and excellent communication skills. Full-time position with pay ranging from $17.00 to $20.00 per hour, health insurance, and paid time off benefits.
Job Description
Regulatory Affairs Assistant PulmonIx 3511 West Market Street, Greensboro, NC 27403 Responsibilities Prepare and submit regulatory documents to the FDA and other regulatory bodies to ensure compliance with applicable regulations. Collaborate with our regulatory coordinator to support clinical trials Conduct research on regulatory requirements and maintain up-to-date knowledge of industry standards. Monitor project timelines, ensuring that all regulatory submissions are completed accurately and on schedule. Provide guidance on compliance management practices to mitigate risks associated with regulatory issues. Participate in meetings with regulatory agencies as needed, representing the organization’s interests. Qualifications Bachelor’s degree in Life Sciences, Chemistry, or a related field; Strong understanding of FDA regulations and guidelines related to drug development and approval processes. Experience with clinical trials, quality assurance, research methodologies, project management, and compliance management is highly desirable. Excellent analytical skills with a keen attention to detail. Strong communication skills, both written and verbal, with the ability to convey complex information clearly. Ability to work collaboratively in a fast-paced environment while managing multiple projects simultaneously.
Job Type:
Full-time Pay:
$17.00 – $20.00 per hour Expected hours: 40 per week
Benefits:
Health insurance Paid time off
Schedule:
Monday to Friday No weekends
Work Location:
In person
