Apply on Employer Site

Skyhawk Therapeutics · 1 day ago

Senior Manager, Regulatory Project Management and Operations

Greater Boston

Full-time

Onsite

Senior Level

$130K/yr - $200K/yr

7+ years exp

Skyhawk Therapeutics is a biotechnology company focused on regulatory project management and operations. They are seeking a Senior Manager to lead the planning, coordination, and delivery of regulatory submissions to global health authorities, ensuring submission readiness and compliance across teams.

BiotechnologyTherapeutics

Responsibilities

Lead end-to-end submission planning for investigational and marketing applications

Assess submission risks and develop mitigation plans to ensure on-time delivery

Partner with Regulatory Lead to define submission strategy, timelines, and deliverables

Manage content planning, authoring assignments, and cross-functional review cycles

Oversee the compilation, formatting, and publishing of regulatory documents in compliance with global eCTD requirements

Act as the operational hub for regulatory submissions, facilitating communication across Regulatory, Clinical, Nonclinical, CMC, Program Management, and other functional teams

Drive submission team meetings, track progress, and mitigate risks

Establish clear roles, responsibilities, and timelines for team members

Manage interactions with external partners to ensure high-quality, timely filing

Evaluate vendor performance and implement process improvements as needed

Qualification

Regulatory submissions experienceECTD knowledgeProject management skillsCross-functional collaborationCommunicationOrganization skillsAttention to detail