Director, Regulatory Affairs - Strategic Biotech Leader

Halozyme, Inc.; San Diego (CA); On-site; USD 215,000 - 230,000; Full time

Benefits offered by this job

Employee Stock Purchase Program

401(k) matching

Tuition reimbursement

Job summary

Halozyme, Inc. in San Diego seeks a Director of Regulatory Affairs to lead strategic regulatory efforts across product teams, ensuring compliant submissions and timely timelines. The role drives CMC controls, interacts with regulators, and mentors teams in a matrix setting.

You’ll guide IND/CTA/BLA submissions, collaborate with R&D, Manufacturing, and external partners, and influence regulatory strategies for clinical and commercial programs.

Qualifications

• BS/BA in a scientific discipline with 10 years in industry, or MS with 6 years experience.
• Minimum 8 years in regulatory affairs disciplines.
• At least 5 years in regulatory affairs management in biotech or pharma.
• Demonstrated leadership in developing and implementing regulatory strategy and interactions.
• Ability to prioritize and lead sophisticated projects, timelines and teams in a matrix environment.
• Creative problem solving; ability to deal with ambiguity and define a path forward.
• Track record of being results-driven and team-focused.
• Excellent written and oral communication skills.
• Experience in preparing and submitting INDs, CTAs, BLAs, MAAs, amendments, supplements.
• Knowledge of cGMPs, GCPs, and global CMC regulations; familiarity with regulators.
• RAC certification desired; strong software/tools knowledge (Veeva RIM, MasterControl, SharePoint).

Responsibilities

• Provide strategic regulatory leadership and direction for quality submissions and CMC controls.
• Guide internal and external teams for submissions to IND/CTA and BLA.
• Interact with domestic and foreign regulatory agencies and partners.
• Lead changes to supply network, including site transfers and QC transfers.
• Mentor regulatory professionals and lead cross-functional teams for timely submissions.
• Maintain up-to-date knowledge of FDA, EMA, PMDA, ICH, WHO guidelines.
• Facilitate approvals for clinical trials, marketing applications, and lifecycle amendments.
• Evaluate CMC change control records and assess regulatory impact.
• Support budget/resource planning for regulatory activities.

Skills

Regulatory leadership

Regulatory strategy

Leadership

Project management

Communication

Cross-functional collaboration

Problem solving

Regulatory interactions

IND/CTA/BL A experience

Education

BS/BA in scientific discipline

MS degree

Tools

Veeva RIM

MasterControl

SharePoint

Windows OS

MS Office Suite

Adobe

Job description

Halozyme, Inc. in San Diego seeks a Director of Regulatory Affairs to lead strategic regulatory efforts across product teams, ensuring compliant submissions and timely timelines. The role drives CMC controls, interacts with regulators, and mentors teams in a matrix setting.

You’ll guide IND/CTA/BLA submissions, collaborate with R&D, Manufacturing, and external partners, and influence regulatory strategies for clinical and commercial programs.