Regulatory Affairs Associate — Streamline Global Submissions

Stark Pharma Solutions Inc; Piscataway Township (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

Stark Pharma is looking for a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices and pharmaceuticals. You will prepare and submit regulatory documentation, maintain compliance, and assist with FDA submissions to ensure adherence to regulatory standards.

The ideal candidate will have 1-3 years of experience in Regulatory Affairs and a Bachelor's degree in a related field. Strong communication skills and project management abilities are essential.

Qualifications

• 1-3 years of Regulatory Affairs experience in the pharmaceutical or healthcare industry.
• Working knowledge of FDA regulations and regulatory submission processes.
• Ability to manage multiple projects and deadlines.

Responsibilities

• Prepare and submit regulatory documentation for product approvals.
• Review product labeling and promotional materials for compliance.
• Monitor changes in regulations and communicate impacts.

Skills

Technical writing

Regulatory compliance

Project management

Verbal communication

Written communication

Education

Bachelor's degree in Regulatory Affairs or related discipline

Job description

Stark Pharma is looking for a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices and pharmaceuticals. You will prepare and submit regulatory documentation, maintain compliance, and assist with FDA submissions to ensure adherence to regulatory standards.

The ideal candidate will have 1-3 years of experience in Regulatory Affairs and a Bachelor's degree in a related field. Strong communication skills and project management abilities are essential.