Regulatory Specialist

4 weeks ago

Rahway, United States iConsultera Full time

Title: Labeling Specialist


• 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.



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


Required Experience and Skills:

• 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


Intake notes:

• Hybrid schedule

• Experience would be preferred over a degree.

• Looking for someone with labeling expertise in the pharmaceutical industry, vaccines manufacturing or GMP.


• Software: MS office


Typical day:

• 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.

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