Senior Director, Global Regulatory Strategy

Halozyme,-Inc.-1; San Diego (CA); On-site; USD 215,000 - 230,000; Full time

Benefits offered by this job

Stock purchase plan

401(k) matching

Tuition reimbursement

Job summary

Halozyme, Inc. is seeking a Director of Regulatory Affairs to lead global regulatory strategies for development and marketed products. You will partner with cross-functional teams to ensure timely submissions and approvals with regulators worldwide.

The role requires extensive leadership, strategic planning, and hands-on experience with INDs, CTAs, and BLAs. Halozyme offers a comprehensive benefits package and opportunities for growth in a collaborative environment.

Qualifications

• BS/BA in a scientific discipline with 10 years of industry experience, or MS degree with 6 years’ experience, or equivalent combination.
• Minimum of 8 years in regulatory affairs.
• 5 years’ experience in regulatory affairs management.
• Experience in INDs, CTAs, BLAs, MAAs, and amendments/submissions.
• Knowledge of cGMPs, GCPs, and global regulatory regulations.

Responsibilities

• Provide strategic regulatory leadership and direction to product teams for regulatory submissions.
• Lead IND/CTA and BLA planning, filings, and responses with global regulators.
• Mentor regulatory professionals and manage cross-functional teams.
• Interact with domestic and international regulatory agencies and partners.
• Maintain up-to-date knowledge of FDA, EMA, PMDA, ICH guidelines.

Skills

Regulatory leadership

Regulatory strategy

Cross-functional teamwork

Communication skills

Project management

Education

BS/BA in a scientific discipline

MS degree in a related field

Regulatory Affairs Certification (RAC)

Tools

Veeva RIM

MasterControl

SharePoint

MS Office

Job description

Halozyme, Inc. is seeking a Director of Regulatory Affairs to lead global regulatory strategies for development and marketed products. You will partner with cross-functional teams to ensure timely submissions and approvals with regulators worldwide.

The role requires extensive leadership, strategic planning, and hands-on experience with INDs, CTAs, and BLAs. Halozyme offers a comprehensive benefits package and opportunities for growth in a collaborative environment.