Senior Manager, Regulatory Operations

Role Summary

The Senior Manager, Regulatory Operations will play a critical role in leading Immunome’s regulatory systems, submissions and documentation processes across our clinical-stage oncology programs. This individual will oversee regulatory information management, publishing, and operational activities to ensure high-quality, timely submissions that meet global regulatory requirements.

Responsibilities

• Lead the planning, formatting, publishing, and submission of global regulatory documents, including INDs, amendments, annual reports, meeting packages, and eCTD submissions.
• Manage document workflows, version control, and archival processes to maintain complete and compliant regulatory records.
• Partner with cross-functional teams to ensure timely delivery of submission components and adherence to regulatory standards.
• Oversee regulatory submission timelines, identifying risks and implementing mitigation strategies.
• Maintain and enhance regulatory systems, including EDMS, RIM, and publishing tools.
• Coordinate Health Authority meeting logistics and regulatory documentation.
• Support development of SOPs, templates, and process improvements.
• Ensure submissions comply with FDA, EMA, ICH, and other global regulations.

Qualifications

• A minimum of 5 years of regulatory operations experience in the biotechnology or pharmaceutical industry.
• Demonstrated experience preparing and publishing eCTD submissions.
• Strong understanding of global regulatory frameworks and submission standards.
• Experience supporting oncology development programs is preferred.

Skills

• Expertise with regulatory publishing tools and regulatory information management systems.
• Strong organizational, project management, and communication skills.
• Proven ability to collaborate effectively across functional teams.
• Detail-oriented with a commitment to high-quality documentation and compliance.

Education

• Bachelor’s degree in a scientific or related discipline is required.