Regulatory Affairs Specialist – Labeling & Submissions

RXinsider LTD.; Cherry Hill Township, Northern (NJ, KY); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

Annual bonus

401k match

Health benefits

Paid vacation/leave

Tuition reimbursement

Career growth

Job summary

RXinsider LTD. is seeking a Regulatory Affairs Associate in New Jersey to support ongoing regulatory activities, including preparation and submission of Annual Reports, APRs, foreign registrations, change controls, and labeling review.

The role involves responding to FDA deficiency letters and drafting amendments for approval. Ideal candidates have a BS in a scientific discipline with 2–5 years in pharma regulatory work, strong communication, and the ability to manage multiple projects with

Qualifications

• BS degree in a scientific discipline with 2–5 years of pharmaceutical regulatory experience.
• Excellent written and verbal communication skills.
• Ability to work independently and manage multiple projects.
• Strong attention to detail and accuracy.
• Regulatory knowledge including FDA processes preferred.

Responsibilities

• Review and approve labeling revisions based on FDA requirements.
• Draft and submit regulatory documents including annual reports and change controls.
• Support foreign registrations and responses to deficiency letters.
• Prepare and submit supplements and amendments to FDA.
• Maintain regulatory databases and track regulatory activities.
• Provide regulatory updates to teams and participate in staff meetings.
• Coordinate with cross-functional groups to gather required documents.

Skills

Independent judgment

Attention to detail

Regulatory knowledge

Written & verbal comms

Project management

Multi-tasking

Education

BS in science

Job description

RXinsider LTD. is seeking a Regulatory Affairs Associate in New Jersey to support ongoing regulatory activities, including preparation and submission of Annual Reports, APRs, foreign registrations, change controls, and labeling review.

The role involves responding to FDA deficiency letters and drafting amendments for approval. Ideal candidates have a BS in a scientific discipline with 2–5 years in pharma regulatory work, strong communication, and the ability to manage multiple projects with