8 Regulatory Operations Specialists - II (Associate) Jobs in Millsboro, DE
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Regulatory Operations Specialists - II (Associate)
$82k-107k (estimate)
Full Time | Investment Management
3 Weeks Ago
Intelliswift Software Inc is Hiring a Regulatory Operations Specialists - II (Associate) Near Millsboro, DE
QualificationsTitle: Regulatory Affairs US Biologicals labeling specialist
Minimum Education: Associate degree.
Preferred Education: Bachelor/Master's degree in Life Science.
Required Experience And Skills
Personality
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.
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.
- Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment.
- 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.
- 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
Job Summary
JOB TYPE
Full Time
INDUSTRY
Investment Management
SALARY
$82k-107k (estimate)
POST DATE
06/05/2024
EXPIRATION DATE
07/20/2024
WEBSITE
intellswift.com
HEADQUARTERS
FREMONT, CA
SIZE
25 - 50
FOUNDED
2001
TYPE
Private
CEO
LADDI S JHUTY
REVENUE
<$5M
INDUSTRY
Investment Management
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About Intelliswift Software Inc
Intelliswift Software provides enterprise application, collaboration, mobility and cloud computing solutions.
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