Senior Regulatory Lead, Clinical Trials (Remote)

Yale Cancer Center; New Haven, Northern (CT, KY); Hybrid; USD 82,000 - 132,000; Full time

Job summary

Yale Cancer Center is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for clinical research protocols from activation through closeout. You will manage submissions, maintenance, and compliance while mentoring junior staff and guiding investigators.

The role requires navigating FDA regulations and GCP, with strong communication and collaboration across teams to meet deadlines and ensure high-quality regulatory practices within a remote work model.

Qualifications

• Proven ability to interpret FDA regulations, GCP guidelines, and other federal regulations.
• Ability to manage multiple regulatory approvals and maintain compliance across studies.
• Strong leadership, mentoring, and cross-functional collaboration skills.

Responsibilities

• Leads regulatory activities for clinical research protocols from activation to closeout.
• Oversees submissions, maintenance, and compliance with regulatory requirements.
• Mentors Regulatory Affairs staff and promotes best practices.
• Shares regulatory expertise to guide investigators and study teams.
• Coordinates with management to ensure timely regulatory processes and audits.

Skills

FDA regulations

GCP guidelines

Regulatory submissions

Project leadership

Communication & collaboration

Education

Bachelor’s degree in life sciences

Tools

Microsoft Office

Job description

Yale Cancer Center is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for clinical research protocols from activation through closeout. You will manage submissions, maintenance, and compliance while mentoring junior staff and guiding investigators.

The role requires navigating FDA regulations and GCP, with strong communication and collaboration across teams to meet deadlines and ensure high-quality regulatory practices within a remote work model.