CMC Lead, Global Regulatory Affairs – Biologics

Teva; West Chester (Chester County); Vor Ort; USD 140.000 - 185.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) plan

Paid time off

Life and disability insurance

Employee stock purchase plan

Zusammenfassung

Teva Pharmaceuticals USA seeks an Associate Director, Global Regulatory Affairs CMC to lead regulatory CMC strategy for innovative and marketed products. You will interface with development, analytical, quality and manufacturing teams across Teva’s network and guide cross-functional projects in a multi-disciplinary setting.

The role involves coordinating with Health Agencies, planning FDA submissions (INDs/NDAs/BLAs), and ensuring regulatory compliance across global registration activities for

Qualifikationen

• Bachelor degree in scientific field or equivalent.
• 5+ years of regulatory affairs experience.
• Familiar with IND and/or NDA/BLA submissions.
• Knowledge of FDA/EMA regulations/guidance.

Aufgaben

• Develop/regulatory CMC strategy as part of a global team.
• Plan and direct regulatory projects; provide technical guidance.
• Review CMC submissions for accuracy and compliance.
• Coordinate with Health Agencies and cross-functional teams.
• Lead preparation of FDA submissions (INDs, NDAs, BLAs) and related reports.

Kenntnisse

Regulatory affairs

IND/NDA/BLA

FDA/EMA knowledge

Communication

Ausbildung

Bachelor's degree in science

Jobbeschreibung

Teva Pharmaceuticals USA seeks an Associate Director, Global Regulatory Affairs CMC to lead regulatory CMC strategy for innovative and marketed products. You will interface with development, analytical, quality and manufacturing teams across Teva’s network and guide cross-functional projects in a multi-disciplinary setting.

The role involves coordinating with Health Agencies, planning FDA submissions (INDs/NDAs/BLAs), and ensuring regulatory compliance across global registration activities for