Senior Director, Regulatory Affairs

Job overview

The Senior Director, Regulatory Affairs position is onsite in Redwood City, CA. Compensation is not specified. ImmunEdge is a biopharmaceutical company developing novel therapeutics for patients with serious or life-threatening diseases. The role leads global regulatory strategy and execution for development programs, translating changing regulatory requirements into practical plans. As a strategic partner to clinical, research, manufacturing, quality, safety, and executive teams, the director guides health-authority engagement and submissions to support therapeutic development and potential registration.

What you'll do

• Develop and execute global regulatory strategies from early development through registration and lifecycle management
• integrate regulatory strategy with clinical, nonclinical, CMC, translational, safety, and corporate plans
• assess regulatory opportunities, risks, and pathways
• lead FDA and other health-authority interactions
• oversee briefing documents, agency responses, and development-stage submissions
• provide strategic oversight for future marketing applications
• represent Regulatory Affairs on cross-functional program teams
• advise on protocols and development plans
• maintain regulatory risk assessments
• monitor regulatory intelligence
• establish scalable processes
• manage external regulatory resources
• build internal Regulatory Affairs capabilities.

What we're looking for

Skills & competencies

senior director

regulatory affairs

biotechnology

drug development

global regulatory strategy

fda engagement

regulatory submissions

ind

cta

redwood city ca

immunedge

clinical-stage therapeutics

Work arrangement

• Weekend coverage required

Benefits & perks

• Annual bonus plan, equity, medical, dental and vision insurance, 401(k), medical and dependent-care FSA plans, Employee Assistance Plan, holidays, and paid time off.

Why this role

Requires a relevant bachelor’s degree and significant progressive Regulatory Affairs experience in biotechnology or pharmaceutical drug development. Direct experience leading FDA interactions is required; experience with EMA and other global health authorities is preferred. Oncology, immunology, biologics, and novel therapeutic experience are preferred.

About the employer

ImmunEdge, Inc is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.