Senior Manager, Global Regulatory Submissions & Publishing

Replimune; Woburn (MA); Hybrid; USD 138,000 - 169,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k match

Paid holidays

Job summary

Replimune in Woburn, MA is seeking a Senior Manager, Global Regulatory Submission Management and Publishing to lead planning, preparation, publishing, QC, and submission of global regulatory dossiers. You will partner with Regulatory Operations, Regulatory Affairs, Medical Writing, Clinical Operations, Biostatistics, Data Management, Quality, and external vendors to deliver compliant submissions.

The role requires extensive expertise in regulatory submission management, eCTD publishing, and

Qualifications

• Minimum 8 years of Regulatory Operations and Regulatory Publishing experience in biotechnology or pharmaceutical industries.
• Experience leading global regulatory submissions from planning through delivery.
• Strong knowledge of FDA/EMA/MHRA/ICH requirements and CTIS/eCTD standards.

Responsibilities

• Lead planning, coordination, preparation, publishing, validation and submission of global regulatory dossiers.
• Publish and transmit submissions per health authority requirements; manage timelines and risks.
• Provide leadership and guidance to the Regulatory Operations team across submission programs.

Skills

Regulatory Operations

Regulatory Publishing

Veeva Vault RIM

Project Management

Leadership

Cross-functional Collaboration

Education

Bachelor’s degree

Tools

Veeva Vault RIM

DXC

eCTD Xpress

ISI Toolbox

StartingPoint

Veeva PromoMats

Job description

Replimune in Woburn, MA is seeking a Senior Manager, Global Regulatory Submission Management and Publishing to lead planning, preparation, publishing, QC, and submission of global regulatory dossiers. You will partner with Regulatory Operations, Regulatory Affairs, Medical Writing, Clinical Operations, Biostatistics, Data Management, Quality, and external vendors to deliver compliant submissions.

The role requires extensive expertise in regulatory submission management, eCTD publishing, and