Regulatory Labeling Specialist -RLS24-06780

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). They ensure that product labeling is updated in accordance with FDA regulations and corporate guidelines, liaising with various departments to ensure compliance. Additionally, they maintain databases and team sites to ensure updated and accurate information.

Responsibilities:

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

Qualifications:

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.