Regulatory Affairs Associate - FDA Submissions

Makro Scientific; Piscataway Township (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading staffing solutions provider in New Jersey is seeking a Regulatory Affairs Associate to prepare and submit annual reports to the FDA. The ideal candidate will have a Master’s degree in Science and at least 3 years of experience in the pharmaceutical industry. Key responsibilities include coordinating submissions and maintaining regulatory databases. Strong communication and computer skills are essential for success in this fast-paced environment. Join a dedicated team and contribute to the success of life sciences companies.

Qualifications

• 3+ years of experience in the Pharmaceutical Industry, specifically in Regulatory Affairs.
• Working knowledge of 21 CFR and US FDA guidance.
• Ability to maintain accuracy and attention to detail.

Responsibilities

• Prepare, review and submit high-quality annual reports with FDA.
• Coordinate with departments for annual report documents.
• Maintain regulatory databases and knowledge of regulations.

Skills

Proofreading abilities

Strong computer skills

Time management

Excellent written communication

Analytical ability

Education

Master Degree in Science or Technical

Tools

MS Word

Excel

Outlook

Adobe Acrobat

Job description

A leading staffing solutions provider in New Jersey is seeking a Regulatory Affairs Associate to prepare and submit annual reports to the FDA. The ideal candidate will have a Master’s degree in Science and at least 3 years of experience in the pharmaceutical industry. Key responsibilities include coordinating submissions and maintaining regulatory databases. Strong communication and computer skills are essential for success in this fast-paced environment. Join a dedicated team and contribute to the success of life sciences companies.