Regulatory Affairs Specialist II

We are seeking an experienced Regulatory Affairs Specialist II to support the development and execution of global regulatory strategies with a strong focus on compliance and operational excellence. This fully onsite role in Princeton, NJ is responsible for ensuring regulatory readiness, maintaining accurate regulatory data, and driving operational efficiency to enable timely market access across multiple jurisdictions.

The ideal candidate will bring 4–6 years of regulatory operations experience within a regulated industry, along with strong knowledge of U.S. FDA and international regulatory requirements.

• Utilize the Regulatory Information Management System (RIMS) to ensure data accuracy, integrity, and process efficiency.
• Perform data analysis, submission/document uploads, data verification, and generate RIMS-based reports to support regulatory strategies, KPIs, and resolution of blocked orders.
• Develop, maintain, monitor, and continuously improve Global Standard Operating Procedures (GSOPs), work instructions, and process controls to ensure regulatory compliance.
• Ensure compliance with applicable U.S. FDA and international regulatory requirements.
• Review and evaluate regulatory processes, documentation, and data to maintain inspection readiness.
• Provide cross-functional support in areas such as regulatory intelligence, UDI implementation, submission publishing, and establishment registrations.

• 4–6 years of regulatory affairs/regulatory operations experience
• Knowledge of FDA regulations and international regulatory frameworks
• Experience authoring and executing SOPs, process documentation, and driving process improvements
• Hands-on experience with regulatory data governance platforms and change management systems (e.g., Veeva Vault, Agile, etc.)
• Familiarity with regulatory submission formats including eStar, eCTD, and paper submissions
• Exposure to process automation tools, dashboards, and analytics platforms (e.g., Power BI, Tableau)

• Experience with Regulatory Information Management Systems (RIMS)
• Knowledge of global UDI databases and requirements
• Experience in regulatory operations within a global organization