Advisor, Regulatory Affairs

Job Description

Ensures the organization gains regulatory approval for new programs and program amendments and other regulated activities. Maintains program licenses and permits. Implements regulatory developments and determining the impact on business operations and compliance programs.

Job Responsibility

• Provides strategic advice and guidance to the Regulatory Affairs function. Leads new and continuing programs to ensure compliance with regulatory standards and policies.
• Recommends improvement and efficiencies regarding operational procedures and policies.
• Advises Investigators and other regulatory staff of appropriate conduct of investigation, preparation of protocol, and consent documents in accordance with applicable regulations
• Oversees the regulatory reporting/documentation for internal and external audiences.
• Prepares and submits regulatory applications such as permits, licenses, certificates, and authorization required by governmental agencies.
• Coordinates government interactions and compliance activities; interacts with regulatory agencies.
• Coordinates regulatory readiness activities, accreditation, certification and recertification efforts
• Collaborates with Research and Corporate Compliance in identifying "for cause" audits and problem resolution
• Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.

Job Qualification

• Bachelor's Degree required, or equivalent combination of education and related experience.
• 10+ years of relevant experience and 2+ years of leadership / management experience, required.

*Additional Salary Detail
The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).