Regulatory Affairs CMC Project Lead coordinating multiple pharmaceutical projects at Sanofi. Providing strategic regulatory guidance, mentoring team members, and ensuring compliance in drug development.
About the role
- Regulatory Coordinator overseeing compliance for oncology clinical trials at Duke Cancer Institute. Leading regulatory operations and mentoring staff to support cancer research initiatives.
Responsibilities
- Oversee regulatory submissions and documentation for clinical trials
- Ensure compliance with institutional, federal, and sponsor requirements
- Lead and mentor a team of regulatory professionals
- Collaborate with sponsors, CROs, and internal stakeholders to resolve regulatory and safety issues
- Manage compliance with institutional policies, NIH Public Access, ct.gov, and Research Data Security Plans
- Lead safety reporting, including timely submission of Adverse Event Reports per institutional and sponsor guidelines
- Supervise and develop staff, providing coaching, performance reviews, and career development opportunities
- Prepare for audits and monitoring visits, addressing findings and ensuring corrective actions
Requirements
- Associate’s degree required
- Bachelor’s degree strongly preferred
- Six years of research or regulatory experience
- Specific Regulatory experience required: Experience with industry sponsors and CROs; Proven ability to manage a large, complex portfolio (30+ therapeutic studies)
- Completion of the DOCR Clinical Research Apprenticeship may substitute for one year
- A Bachelor’s degree may substitute for two years of experience
- Oncology experience preferred
- Academic clinical research experience strongly preferred
Benefits
- Comprehensive and competitive medical and dental care programs
- Generous retirement benefits
- Wide array of family-friendly and cultural programs
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Junior GRC Analyst supporting Governance, Risk and Compliance for technology and legal services at LEAP. Collaborating with senior stakeholders to maintain compliance posture and risk management activities.
Regulatory Affairs Specialist ensuring compliance for global product distribution at BD. Responsible for maintaining high - quality regulatory data and collaborating across multiple functions.
Manager, Environmental Compliance leading Rockwell Automation's global environmental compliance program across industrial automation portfolio. Strategic leadership for regulatory execution and compliance governance.
Senior Quality Compliance Manager leading governance and improvement of Quality Management System at Medline. Overseeing QMS activities and ensuring regulatory compliance throughout product lifecycle.
Compliance Manager overseeing on - site warehouse compliance, ensuring risk mitigation and training. Collaborating with leadership to uphold regulatory standards and implement compliance procedures.
Staff Program Cost Control Analyst supporting EVM Compliance at Northrop Grumman. Ensuring compliance with EVMS policies while working across multiple program teams.
Head of Trust, Risk & Regulatory to ensure AI - driven financial infrastructure meets regulatory standards. Collaborate with product and engineering to translate regulations into strategic frameworks.
Senior Regulatory Professional developing regulatory strategies for Novo Nordisk's GLP - 1 portfolio. Collaborating with cross - functional teams in submission processes to Health Authorities.
Compliance Manager ensuring adherence to Google policies in digital marketing campaigns at AMO Publishing. Engaging in data moderation and compliance monitoring in a media tech environment.