Position : Associate Regulatory Operations Specialists

Location : Rahway, NJ

Duration : 1 Year

Job Summary :

Under general supervision, the Associate Regulatory Operations Specialist is responsible for preparing high-quality labeling documents for submission to the US Food and Drug Administration (FDA).

Additionally, they maintain databases and team sites to ensure updated and accurate information.

Responsibilities :

• Prepare high-quality labeling documents for submission to the FDA.
• Ensure product labeling is updated in accordance with FDA regulations and corporate guidelines.
• Coordinate with departments such as Marketing, Pharmacovigilance, and Technical Services to ensure compliance.
• Maintain databases and team sites with updated and accurate information.

Qualifications : Education :

Education :

Associate / Bachelor of Life Science / Master's degree.

Required Experience and Skills :

• Associate's Degree : Minimum 5 years of relevant experience within pharmaceutical labeling.
• Bachelor's Degree : Minimum 3 years of relevant experience within pharmaceutical labeling.
• Master's Degree : Minimum 2 years of relevant experience within pharmaceutical labeling.
• Scientific background or familiarity with medical terminology.
• Proficient in Microsoft Office, Excel, Word, Outlook, and SharePoint.
• Excellent English oral and written communication and presentation skills.
• Experience in the Pharmaceutical Industry, Vaccine Manufacturing, or Medical and Biotechnology sectors.

Personality :

• Attention to detail.
• Ability to work independently and as a team player.
• Excellent communication and written skills.

Note :

• 1-year assignment with the possibility of extension.
• Hybrid schedule requiring onsite presence for 3 days per week (Tuesday and Wednesday fixed), with the 3rd day optional.
• Manager prefers experience over education.

Last updated : 2024-05-03