U.S. Biosimilars Regulatory Lead — Hybrid Work

U023 (FCRS = US023) Sandoz Inc; Princeton (NJ); Hybrid; USD 145,600 - 279,400; Full time

Benefits offered by this job

Competitive salary

Generous health insurance

Retirement savings plan

Paid time off

Job summary

Sandoz Inc in Princeton, NJ, is looking for an Associate Director of Regulatory Affairs – Biosimilars to lead U.S. regulatory strategy for biosimilar development. This pivotal role involves overseeing regulatory submission processes and ensuring compliance with FDA regulations while collaborating cross-functionally for timely approvals.

The ideal candidate will have at least 7 years of experience in regulatory affairs with a strong focus on biosimilar programs, supported by a relevant academic background. The position offers a competitive salary along with a hybrid work environment.

Qualifications

• Minimum 7 years regulatory affairs experience within the biopharmaceutical industry.
• Strong working knowledge of FDA regulations, guidance, and processes.
• Demonstrated experience preparing regulatory submissions and leading FDA interactions.

Responsibilities

• Lead and manage the preparation and submission of regulatory applications.
• Provide regulatory strategy and guidance to cross-functional teams.
• Serve as a key regulatory liaison throughout the product lifecycle.

Skills

Regulatory & Compliance Expertise

Project & Portfolio Management Expertise

Communication & Interpersonal Skills

Analytical & Problem-Solving Skills

Strategic Leadership & Vision

Education

Bachelor's degree in Life Sciences

Advanced degree (MS, PhD, PharmD) preferred

Job description

Sandoz Inc in Princeton, NJ, is looking for an Associate Director of Regulatory Affairs – Biosimilars to lead U.S. regulatory strategy for biosimilar development. This pivotal role involves overseeing regulatory submission processes and ensuring compliance with FDA regulations while collaborating cross-functionally for timely approvals.

The ideal candidate will have at least 7 years of experience in regulatory affairs with a strong focus on biosimilar programs, supported by a relevant academic background. The position offers a competitive salary along with a hybrid work environment.