Regulatory Affairs Specialist II_US

5x a week in Princeton, NJ office, normal business hours.

Experienced professional who supports the development and execution of regulatory strategies with a strong focus on global compliance. This role is responsible for managing Regulatory Operations activities by ensuring regulatory readiness, operational efficiency, and timely market access by maintaining accurate regulatory data in RIMS, scalable global processes, and inspection‑ready documentation across multiple jurisdictions. Also supports cross‑functional areas such as regulatory intelligence, UDI, publishing, and establishment registrations.

Utilizes knowledge of all applicable laws and regulations that apply to the industry worked in, and assures staff members are aware of the legal standards that apply to their work and that they are followed. Reviews the processes used in their industry, and establishes guidelines and standards for specific tasks. Evaluates the processes in place and reviews data and documents. Bachelor's Degree is required.

4-6 years of experience.

• Prior experience with authoring and executing standard operating procedures, process documentation and automation.
• Prior experience with regulatory data governance platforms and change management systems (e.g., Veeva Vault, Agile, etc.)
• Exposure to process automation, dashboards, or analytics (Power BI, Tableau, etc.)
• Familiarity with regulatory submission formats, including eStar, eCTD, and paper submissions.
• Must possess and demonstrate an understanding of FDA Regulations and international regulations.

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”