Summary: The Regulatory Affairs Manager (Level 3) is responsible for oversight of regulatory operations and strategic objectives across the clinical research site network. This leadership position ensures compliance with regulatory guidelines and internal policies, while mentoring team members and collaborating with sponsors and IRBs.

Duties and Responsibilities: The Regulatory Affairs Manager:

• Oversees all regulatory submissions, communications, and documentation across studies.
• Establishes and implements regulatory strategies and workflows to optimize efficiency.
• Supervises and trains Regulatory Specialists and Assistants.
• Liaises with sponsors, IRBs, and clinical teams to resolve regulatory issues.
• Ensures compliance with applicable regulations, SOPs, and ALCOA-CCEA principles.
• Audits regulatory files and oversee document QC and version control.
• Prepares for and lead site regulatory inspections and sponsor audits.
• Evaluates and implement new tools or systems for regulatory operations.
• Occasional travel to Company sites, Investigator meetings, and/or Company meetings as required.
• Performs other miscellaneous job-related duties as assigned by their manager.

Requirements:

• Bachelor’s degree in life sciences or a related field required.
• 5+ years of experience in clinical research regulatory affairs with at least 1 year in a leadership role.
• Advanced understanding of FDA, ICH-GCP, HIPAA, and IRB requirements.
• High proficiency in Microsoft Office and CTMS platforms (e.g., RealTime).
• Strong organizational, leadership, and interpersonal communication skills.
• Certification required: RAC preferred, or ACRP-CP, or SOCRA CCRP.

Continuing Education:

• GCP (Good Clinical Practice) – Must renew every 3 years
• OSHA trainings

Physical Requirements and Environmental Factors:

• Continually required to sit.
• Continually required to utilize hand and finger dexterity.
• Continually required to talk or hear.
• The employee must occasionally lift and/or move up to 10 pounds.
• Travel is required up to 15% of the time.

Equal Opportunity: Elixia is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, age, sex, gender, sexual orientation, disability, or any other characteristic protected by law. You must be able to perform the essential functions of the position satisfactorily. Reasonable accommodation may be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.

About Elixia

Elixia was founded to improve the quality of life for millions of Americans through scientific research. Given the challenges in patient recruiting and the increased complexity around clinical trials, Elixia is focused on the opportunity to achieve efficiencies in a highly fragmented sector. Elixia provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.