Global CMC Regulatory Lead for Post-Approval Submissions

Arrowhead Pharmaceuticals; Verona (WI); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Competitive salaries

Excellent benefit package

Job summary

Arrowhead Pharmaceuticals is seeking a Sr Manager Regulatory CMC in Verona, WI. This position involves leading post-approval change management activities across diverse modalities, ensuring compliance with global requirements. The ideal candidate should have a BS/BA in a scientific discipline, 8+ years in the biopharmaceutical industry, and strong experience in regulatory CMC. The role offers competitive salaries and a comprehensive benefits package.

Qualifications

• 8+ years of overall biopharmaceutical/device industry experience.
• 5+ years of direct Regulatory CMC experience required.
• Proven ability to develop global regulatory strategy recommendations.

Responsibilities

• Lead post-approval change management activities and regulatory submissions.
• Explore and implement automation technologies for efficiency.
• Ensure site compliance with global regulatory requirements.

Skills

Regulatory strategy communication

Automation technologies implementation

Global HA requirements knowledge

Post-approval change management

Education

BS/BA Degree in a Scientific Discipline

Advanced Degree (M.S., Ph.D.) preferred

Tools

CMC Life Cycle Management Systems (Veeva Registrations)

Job description

Arrowhead Pharmaceuticals is seeking a Sr Manager Regulatory CMC in Verona, WI. This position involves leading post-approval change management activities across diverse modalities, ensuring compliance with global requirements. The ideal candidate should have a BS/BA in a scientific discipline, 8+ years in the biopharmaceutical industry, and strong experience in regulatory CMC. The role offers competitive salaries and a comprehensive benefits package.