Regulatory Affairs Specialist Jobs

You must work EST time zone.

Job brief

Serves as the primary specialist on regulatory affairs processes for clinical research studies. Assists in mentoring and training of Regulatory Affairs Specialists I.

Responsibilities

• Manages, implements, and evaluates all aspects of regulatory activities and strategies including submissions and facilitation of responses at time of study initiation, execution/maintenance and close out.
• Collaborates with Investigators and Regulatory Managers to prepare and execute corrective and preventative action plans and ensure implementation and adherence to stated plan.
• Oversees the maintenance of attributable, legible, contemporaneous, original, accurate and complete regulatory documentation to substantiate the essential documents for clinical research trials.
• Identifies instances of noncompliance and deviations from the protocol and regulatory requirements, evaluates each instance to determine appropriate corrective and preventative action, and drafts reports for submission to the appropriate parties and committees.
• Assesses regulatory activities program wide and identify areas for improvement or that require correction and provides recommendations, as needed.
• Maintains knowledge of changing regulations and policies governing clinical research and assesses the impact of such changes on the regulatory affairs department.
• Provides input to the Quality Education Unit to design Regulatory Specialist trainings and continuing education.
• Creates reports and makes recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH Good Clinical Practices, federal regulations, and institutional processes.
• Explains regulations, policies and procedures to guide others on regulatory and compliance matters.
• Ensures study protocol submissions, reviews and reporting requirements are met per ICH/GCP, applicable federal regulations, and institutional and sponsor policies and procedures.

Requirements and skills

• Monitors, interprets, applies, and communicates new and revised federal and state regulations, and local/institutional policies and guidance.
• Prepares written documentation as required by the profession and the department; maintains, distributes, analyzes, and projects information for required records, reports and statistics as directed.
• Maintains established departmental policies and procedures, objectives, quality assurance programs, safety, and compliance standards.
• Initiates preparation for interim monitoring visits, internal audits and external audits/inspections for highly complex clinical research studies.

Required Education and Experience:

Bachelor’s degree in life sciences or other health related discipline required and a minimum of three (3) years’ experience in regulatory affairs support.

Required Skill/Ability 1:

Interprets and applies advanced knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, institutional and sponsor practices, standards, policies, and procedures at the unit/functional level. Experience interpreting highly complex clinical trial protocols.