Associate Director, Regulatory Affairs CMC Biologics/Combo

Teva Pharmaceuticals; West Chester (Chester County); Vor Ort; USD 130.000 - 190.000; Vollzeit

Benefits dieser Stelle

Health Insurance

401(k) with company match

Paid time off and holidays

Life and disability insurance

Tuition assistance

Zusammenfassung

Teva Pharmaceuticals in the United States is seeking an Associate Director, Global Regulatory Affairs (CMC) to support development of innovative molecules and product registrations. You will compile and assess regulatory documents, coordinate with global colleagues, and provide CMC strategy and submission support for commercial and development programs across biologics.

You will interface with development, analytical, quality and manufacturing groups, lead cross-functional teams for CMC

Qualifikationen

• Bachelor degree in scientific field or equivalent combination of education and related work experience.
• At least 5 years of regulatory affairs or relevant pharmaceutical industry experience.
• Must be familiar with IND and/or NDA/BLA submission requirements.
• Working knowledge of FDA/EMA regulations / guidance applicable to registration and approval of drugs or biologics.
• Excellent communication and organizational skills.

Aufgaben

• Lead regulatory CMC strategy as part of a multi-disciplinary project team.
• Plan and direct projects and provide technical background to cross-functional colleagues.
• Review CMC submissions for accuracy, completeness and regulatory compliance.
• Manage day-to-day project activities related to assigned products (INDs/NDAs/BLAs).
• Coordinate with agencies and internal regulatory departments; oversee FDA submissions.

Kenntnisse

Regulatory strategy

IND/NDA/BLA submissions

FDA/EMA regulations

Cross-functional leadership

Communication

Ausbildung

Bachelor's degree in science

Jobbeschreibung

Teva Pharmaceuticals in the United States is seeking an Associate Director, Global Regulatory Affairs (CMC) to support development of innovative molecules and product registrations. You will compile and assess regulatory documents, coordinate with global colleagues, and provide CMC strategy and submission support for commercial and development programs across biologics.

You will interface with development, analytical, quality and manufacturing groups, lead cross-functional teams for CMC