Regulatory Operations Specialists

3 weeks ago


De Soto, United States HonorVet Technologies Full time

*** Animal Health is a Biotechnology Center of Excellence that manufactures, fills, packages, and distributes vaccines for animals. This position is responsible but is not limited to the following duties: •Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance. •Support regulatory filing submissions with the USDA for both domestic and international product packaging. •Independently work with internal stakeholders, regulated packaging processes and system workflows to revise or draft new packaging for vaccine biologicals for both US (domestic) and international markets. •Ensure prompt availability of labels and artworks and liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations. Training •Training with the USDA regulations on packaging, ARTIS computer system and internal processes and workflows for packaging submissions and filing maintenance. •Training Type: Corporate Development - Coaching Quals Title: Regulatory Affairs US Biologicals labeling specialist Minimum Education: Associate degree. Preferred Education: Bachelor/Master's degree in Life Science. Required Experience and Skills: •With Associate, minimum 3-5 years of relevant experience within pharmaceutical labeling experience. •With Bachelor's, minimum 0-3 years of relevant experience within pharmaceutical labeling experience. •With Master's minimum 0-2 year of relevant experience within pharmaceutical labeling experience. •Require someone with scientific background or familiarity with medical terminology. •Require someone with excellent proofreading skills. •Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook,SharePoint, ADOBE. Preferred/nice to have: Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology Personality: •Attention to details. •Team Player. •Able to follow directions. •Can work independently once the trainings are complete. •Able to make sure that regulations are met. •Excellent communication and written skills. •Open minded. Note: •Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment. •DO NOT submit PHD.



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