Regulatory Affairs Manager

Role Overview

• Ensure research regulatory lifecycle compliance of assigned projects.
• Serve as programmatic subject matter expert (SME) for regulatory affairs actions, compliance with federal and military-specific regulations, good documentation practices (GDP), and general good research practices (GRP).
• Advise study team members on good research practices and answer ad hoc study conduct-related questions that arise throughout the research lifecycle.
• Oversee, prepare, and track regulatory lifecycle actions submitted to the Institutional Review Board (IRB) spanning from initial submissions to continuing review submissions, protocol amendments/modifications, reportable events, and closure reports, etc.
• Lead the development of initial submission packages for new projects.
• Assist with the development of essential research documents such as protocols, informed consent documents, HIPAA authorizations, etc.
• Create and maintain complete electronic regulatory binders for each study in the program.
• Negotiate, coordinate, and track the execution of IRB reliance agreements, as appropriate.
• Promote safety and confidentiality of research participants at all times.
• Develop and disseminate live trainings, educational materials, templates, and SOPs to program investigators and study team members.
• Supervise the day-to-day activities of assigned regulatory affairs program staff.
• Provide direction, address questions, and provide skills/knowledge transfer.
• Oversee workload and productivity.
• Provide regular summaries and updates to Program Supervisor.
• Plan and facilitate individual and team meetings.
• Lead performance review processes for assigned regulatory affairs staff.
• In collaboration with Geneva People Operations and Program Supervisor, conduct counseling and corrective action, as appropriate.

Requirements

• Bachelor’s degree or equivalent work experience required
• Regulatory Affairs and IRB submission experience required
• 3-5 years’ clinical research experience required
• 3-5 years military/DoD research experience preferred
• 3-5 years experience in FDA-regulated clinical trials preferred
• 1-2 years management/supervisory experience strongly preferred
• Ability to provide strong leadership, innovative thinking, creative planning, and effective motivation skills to staff required
• Ability to exercise independent judgement in a fast-paced, high-pressured environment, accommodate strict deadlines, and manage multiple projects required
• Must demonstrate high quality oral and written communication skills
• Must be organized, have strong attention to detail, and possess a positive, friendly and professional demeanor
• Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner.

Benefits

• medical, dental, and vision healthcare
• Flexible Spending Account
• Health Savings account, with employer contribution
• Short-and long-term disability
• Employee Assistance Program
• Life & ADD insurance
• 403b retirement plan with generous employer match
• flexible leave options
• 11 paid holidays per year
• up to 4 weeks of paid time off in a rolling year
• Employees may qualify for PSLF as Geneva is a 501(c)(3) nonprofit organization.