Regulatory Operations Specialists

4 weeks ago

Rahway, United States Intelliswift Software Inc Full time
Qualifications:
Title: Labeling Specialist 

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

Personality:
• Attention to details
• Team Player
• Can work independently
• Excellent communication and written skills

Note:
• 1 year assignment with possibility of extension
• Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day is optional.
• Manager will prefer someone with experience over a degree/education.

Responsibilities:
• 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.

Comments/Special Instructions
• 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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