8 Regulatory Operations Specialists - II Jobs in Millsboro, DE
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Regulatory Operations Specialists - II
$97k-124k (estimate)
Full Time
2 Weeks Ago
AA2IT is Hiring a Regulatory Operations Specialists - II Near Millsboro, DE
Title - Pharmaceutical Labeling Specialist
Location - Millsboro, DE (hybrid remote with 3 days onsite)
Duration - 18 months
Pay Rate - $26/hr
Responsibilities -
Location - Millsboro, DE (hybrid remote with 3 days onsite)
Duration - 18 months
Pay Rate - $26/hr
Responsibilities -
- 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.
- Label review and submission of labeling documents and artwork
- Quality check for label content and formatting as per FDA guidelines.
- Support the team with the review, revising labeling.
- Prepare the label content following SOP's and FDA regulations.
- Associate degree minimum, Bachelor/Master's degree in Life Science preferred
- Scientific background or familiarity with medical terminology
- Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology experience preferred
- Excellent proofreading skills
- Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook,SharePoint, and Adobe.
- 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
Full Time
SALARY
$97k-124k (estimate)
POST DATE
06/13/2024
EXPIRATION DATE
07/01/2024
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