CMC Regulatory Affairs Director — Global Submissions Lead

Teva Pharmaceuticals; West Chester (Chester County); Vor Ort; USD 150.000 - 230.000; Vollzeit

Benefits dieser Stelle

Health Insurance

401(k) with employer match

Paid Time Off

Life and Disability Insurance

Tuition Assistance

Zusammenfassung

Teva Pharmaceuticals is seeking a Director, Regulatory Affairs CMC to develop and lead regulatory strategies for innovative molecules and products. The role requires coordinating CMC submissions, collaborating with global regulatory teams, and ensuring compliant CMC sections across filings with major health authorities such as the FDA.

The position includes leading cross-functional teams, managing timelines, and influencing regulatory outcomes across global projects.

Qualifikationen

• Bachelor’s degree in scientific discipline required.
• At least 8 years in the pharmaceutical industry.
• At least 5 years in Regulatory Affairs.

Aufgaben

• Develop regulatory strategies to support development of innovative molecules and products.
• Compile, organize and assess documents for regulatory submissions to major health authorities.
• Coordinate with global regulatory colleagues on dossiers for global registration.
• Identify and evaluate CMC issues across development, manufacturing and labeling.
• Lead cross-functional teams for CMC projects and plan meetings with FDA.

Kenntnisse

Regulatory expertise

CMC knowledge

Regulatory strategy

Ausbildung

Bachelor’s degree in science

Advanced degree preferred

Jobbeschreibung

Teva Pharmaceuticals is seeking a Director, Regulatory Affairs CMC to develop and lead regulatory strategies for innovative molecules and products. The role requires coordinating CMC submissions, collaborating with global regulatory teams, and ensuring compliant CMC sections across filings with major health authorities such as the FDA.

The position includes leading cross-functional teams, managing timelines, and influencing regulatory outcomes across global projects.