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Regulatory Operations Specialist
iConsultera Millsboro, DE
$86k-112k (estimate)
Contractor 1 Week Ago
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iConsultera is Hiring a Regulatory Operations Specialist Near Millsboro, DE

Note:

• Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment.

*** 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.

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.

Job Summary

JOB TYPE

Contractor

SALARY

$86k-112k (estimate)

POST DATE

06/19/2024

EXPIRATION DATE

07/17/2024

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The following is the career advancement route for Regulatory Operations Specialist positions, which can be used as a reference in future career path planning. As a Regulatory Operations Specialist, it can be promoted into senior positions as a Regulatory Affairs Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Operations Specialist. You can explore the career advancement for a Regulatory Operations Specialist below and select your interested title to get hiring information.