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Regulatory Operations Specialists

1 month ago

Millsboro, United States Careerbuilder-US Full time

Job Title: Regulatory Operations Specialists - II

Job Location: Millsboro, DE

Job Duration: 14 months+

Shift: 8am-5pm

Job Description:

Client 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.

Qualifications:

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

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