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Regulatory Operations Labeling Associate

1 month ago

Millsboro, United States Net2source Full time

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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