Senior Director, Global Regulatory Strategy

ImmunEdge, Inc; Redwood City (CA); On-site; USD 260,000 - 380,000; Full time

Benefits offered by this job

Annual bonus

Equity

Comprehensive health insurance

401k plan

FSAs (Medical, Dependent)

Job summary

ImmunEdge, Inc. is seeking an experienced Regulatory Affairs leader to craft and execute global strategies for supporting a portfolio of innovative therapeutics.

This executive will partner across Clinical Development, CMC, Nonclinical, Quality, and Pharmacovigilance to translate regulatory requirements into actionable development plans. The ideal candidate will drive interactions with FDA and global authorities, assess expedited pathways, and align submissions with corporate objectives.

Qualifications

• Bachelor's degree in a relevant scientific or health related discipline required.
• Significant progressive experience in Regulatory Affairs within biotechnology or pharmaceutical drug development.
• Direct experience leading interactions with the FDA required. Experience with EMA and other global health authorities strongly preferred.

Responsibilities

• Develop and execute global regulatory strategies for assigned development programs from early development through registration and lifecycle management.
• Lead preparation of briefing documents, meeting requests, responses to regulatory questions, and other agency communications.
• Provide regulatory leadership in the development of protocols, regulatory documents, and submission content.
• Build trusted partnerships across the organization and establish Regulatory Affairs as a proactive contributor to development strategy.

Skills

Regulatory Strategy

FDA Interactions

Biotech/Pharma

Regulatory Leadership

Cross-functional Collaboration

Education

Bachelor's degree in a relevant scientific or health related discipline

Advanced scientific, medical, or regulatory degree preferred

Job description

ImmunEdge, Inc. is seeking an experienced Regulatory Affairs leader to craft and execute global strategies for supporting a portfolio of innovative therapeutics.

This executive will partner across Clinical Development, CMC, Nonclinical, Quality, and Pharmacovigilance to translate regulatory requirements into actionable development plans. The ideal candidate will drive interactions with FDA and global authorities, assess expedited pathways, and align submissions with corporate objectives.