Regulatory Affairs Manager
The Geneva Foundation
full-time
Posted on:
Location Type: Hybrid
Location: Bethesda • Maryland • Virginia • United States
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Salary
💰 $90,000 - $105,000 per year
About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory lifecycle compliancegood documentation practicesgood research practicesIRB submissionclinical researchFDA-regulated clinical trialsprotocol developmentinformed consent documentsHIPAA authorizationselectronic regulatory binders
Soft Skills
leadershipinnovative thinkingcreative planningeffective motivationindependent judgementorganizational skillsattention to detailoral communicationwritten communicationflexibility
Certifications
Bachelor's degree