Biosimilars Regulatory Affairs Manager

U023 (FCRS = US023) Sandoz Inc; Princeton (NJ); Hybrid; USD 114,100 - 211,900; Full time

Benefits offered by this job

Health insurance

Generous paid time off

Retirement savings match

Potential sign-on bonus

Job summary

Sandoz Inc in Princeton, NJ, is seeking a Regulatory Affairs professional to join their biosimilar team. This role involves supporting the regulatory strategy and managing documentation for product submissions.

The ideal candidate should have a Bachelor's degree in a science and 3-5 years of experience in regulatory affairs. The position offers a competitive salary range and a flexible hybrid working approach, allowing for up to 50% remote work.

Qualifications

• 3-5 years experience in regulatory affairs, preferably in biosimilars.
• Fluent English (oral and written) required.

Responsibilities

• Participate in Global RA project meetings and provide input into global strategy for US submissions.
• Implement the agreed upon strategies for assigned projects.
• Prepare US eCTD documents and facilitate timely submissions and approvals to support the biosimilar pipeline.

Skills

Regulatory & Compliance Expertise

Project & Portfolio Management Expertise

Communication and Interpersonal Skills

Analytical and Problem-Solving Skills

Writing and Documentation Skills

Education

Bachelor in a science

Job description

Sandoz Inc in Princeton, NJ, is seeking a Regulatory Affairs professional to join their biosimilar team. This role involves supporting the regulatory strategy and managing documentation for product submissions.

The ideal candidate should have a Bachelor's degree in a science and 3-5 years of experience in regulatory affairs. The position offers a competitive salary range and a flexible hybrid working approach, allowing for up to 50% remote work.