Regulatory Specialist - Rahway, United States - iConsultera

Description

• Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA).
• Ensure that product labeling is updated in accordance with FDA regulations and corporate guidelines.
• Ensure prompt availability of labels and artworks and liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations.
• Maintain databases and team sites by ensuring updated and accurate information is uploaded.

• With Associate, minimum 5 years of relevant experience within pharmaceutical labeling experience
• With Bachelor's, minimum 3 years of relevant experience within pharmaceutical labeling experience
• With Master's minimum 2 years of relevant experience within pharmaceutical labeling experience
• Require someone with scientific background or familiarity with medical terminology.
• Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, and SharePoint.
• Excellent English oral and written communication skills and presentation skills.
• Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology

• Hybrid schedule
• Experience would be preferred over a degree.
• Looking for someone with labeling expertise in the pharmaceutical industry, vaccines manufacturing or GMP.

• Very intensive label-oriented job
• Need someone to hit the ground running.
• Lot of label review and submission.
• Quality check for label content and formatting as per FDA guidelines.
• Support the team with the review, revising labeling.
• Attention to details.
• Will review labels on packaging, container, carton boxes.
• Will prepare the label content following SOP's and FDA regulations.