Director, Regulatory Affairs – Global Strategy Lead

Halozyme Therapeutics Inc.; San Diego; On-site; MXN 4,005,000 - 4,285,000; Full time

Benefits offered by this job

Employee Stock Purchase Program

401(k) matching

Tuition reimbursement

Growth opportunities through in-house/

Job summary

Halozyme Therapeutics Inc. is seeking a Director, Regulatory Affairs to lead the co-development and implementation of global regulatory strategies for both marketed and development products.

You will work with cross-functional teams to ensure timely submissions and approvals of INDs/CTAs, BLAs, and related filings, while mentoring regulatory professionals and managing budgets. The role requires a seasoned regulatory leader with strong problem-solving skills, excellent communication, and the

Qualifications

• 10 years of industry experience in regulatory affairs

Responsibilities

• Lead global regulatory strategies for marketed and development products.

Skills

Strategic regulatory leadership

Cross-functional collaboration

Regulatory strategy development

Regulatory risk management

Leadership and mentorship

Project management in matrix teams

Regulatory submissions planning

Communication skills

Education

BS/BA in a scientific discipline

MS in a scientific discipline

Tools

Veeva RIM

MasterControl

SharePoint

MS Office Suite

Adobe

Job description

Halozyme Therapeutics Inc. is seeking a Director, Regulatory Affairs to lead the co-development and implementation of global regulatory strategies for both marketed and development products.

You will work with cross-functional teams to ensure timely submissions and approvals of INDs/CTAs, BLAs, and related filings, while mentoring regulatory professionals and managing budgets. The role requires a seasoned regulatory leader with strong problem-solving skills, excellent communication, and the