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Regulatory Operations Labeling Associate
1 month ago
Title: Regulatory Operations Specialists Labeling Associate
Duration: 12+ months (Possible Conversion)
Location: Millsboro, DE Hybrid (3 days onsite).
Schedule: Business days and hours
Pay rate: $26.50/hr on W2.
Job Description:
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.
Note:
• Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment.
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
Qualifications:
Title: Regulatory Affairs US Biologicals Labeling Specialist
Minimum Education: Associate degree.
Preferred Education: Bachelor/Masters degree in Life Science.
Required Experience and Skills:
• With Associate, minimum 3-5 years of relevant experience within pharmaceutical labeling experience.
• With a Bachelors, a minimum 0-3 years of relevant experience within pharmaceutical labeling experience.
• With a Masters minimum 0-2 year of relevant experience in pharmaceutical labeling experience.
• Require someone with a 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, and ADOBE.
Preferred/nice to have: Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology
Personality:
• Attention to detail.
• Team Player.
• Able to follow directions.
• Can work independently once the training is complete.
• Able to make sure that regulations are met.
• Excellent communication and writing skills.
• Open minded.
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