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Regulatory Operations Specialists - Rahway, United States - Experis
Description
Our client, one of the largest Pharma companies in the U.S., is looking for an Regulatory Operations Specialist in their Rahway New Jersey Location Job Title:
Regulatory Operations Specialists Location:
Rahway New Jersey (Hybrid)
About the Role:
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 andBiotechnology 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.Why Work for Us:
Here at Experis, we care about people and the role of work in their lives.
We respect people as individuals, trusting them, supporting them, and enabling them to achieve their aims in work and in life.
We have been recognized in multiple ways for our ability to do this successfully.If you are interested in working with us and learning more about this opportunity, click the apply button now and start the path of a new adventure.