Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Oversee the activities of physicians and clinical teams concerning the creation and upkeep of vital regulatory documents.

• Ensure adherence to regulatory requirements.

• Maintain regulatory documentation mandated by the FDA and GCP for specific sites, studies, sponsors, and/or networks.

• Verify that regulatory documentation aligns with local SOPs regarding format and content.

• Develop and manage essential regulatory documents for designated studies.

• Complete regulatory documents punctually to adhere to departmental and sponsor timelines.

• Keep physician credentials up to date.

• Revise and/or create informed consent forms.

• Oversee modifications or amendments to protocols and consent forms in accordance with IRB policy and HIPAA regulations.

• Collaborate closely with regulatory affairs management, the department director, and/or primary investigators.

• Enhance regulatory processes while effectively managing multiple tasks and meeting tight deadlines.

• Handle an increased study workload with minimal supervision.

⛳️ Requirements

• Minimum of a High School Diploma or GED.

• A Bachelor’s Degree or an equivalent combination of education and experience may be accepted.

• At least 3 years of experience in the role of Regulatory Affairs Specialist.

• Strong familiarity with scientific and clinical research terminology.

• Understanding of IRB, FDA, and GCP guidelines.

• SOCRA Certification and/or ACRP Certification is highly preferred.

• Must have US-based work authorization/location; visa sponsorship is not available.

🏝️ Benefits

• Comprehensive benefits that promote physical, mental, and financial wellness.

• Opportunities for annual bonuses or long-term incentives may be available.

• Relocation assistance is not provided.

• Visa sponsorship is not available.