Regulatory Affairs Specialist
2 weeks ago
Katalyst Healthcares & Life Sciences is seeking a highly skilled Regulatory Affairs Biologicals Labeling Specialist to join our team.
Responsibilities:- Regulatory Compliance: Ensure compliance with regulatory requirements for biologicals labeling, including USDA submissions and maintenance of regulatory documents.
- Labeling and Packaging: Prepare new and revised label packaging for regulatory submissions, working closely with internal stakeholders and regulated packaging processes.
- Regulatory Filing: Support regulatory filing submissions with the USDA for domestic and international product packaging.
- Collaboration: Work independently with internal stakeholders to revise or draft new packaging for vaccine biologicals, ensuring compliance with established regulations.
- Documentation: Ensure prompt availability of labels and artworks, liaising with departments such as Marketing, Pharmacovigilance, and Technical Services.
- Education: Associate's degree with 3-5 years of relevant experience, or Bachelor's degree with 0-3 years of experience, or Master's degree with 0-2 years of experience.
- Experience: Minimum 3-5 years of relevant experience in pharmaceutical labeling, with a scientific background or familiarity with medical terminology.
- Skills: Excellent proofreading skills, proficiency in standard computer programs such as Microsoft Office, Excel, Word, Outlook, SharePoint, and ADOBE.
- Industry Knowledge: Preferred experience in the pharmaceutical industry, vaccine manufacturing, or medical and biotechnology.
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South Plainfield, New Jersey, United States Katalyst Healthcares & Life Sciences Full timeJob Title: Regulatory Affairs Biologicals Labeling SpecialistKatalyst Healthcares & Life Sciences is seeking a highly skilled Regulatory Affairs Biologicals Labeling Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for preparing new and revised label packaging for regulatory submissions to the USDA and...
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Regulatory Affairs Specialist
1 week ago
South Plainfield, New Jersey, United States Katalyst Healthcares & Life Sciences Full timeJob Title: Regulatory Affairs Biologicals Labeling SpecialistKatalyst Healthcares & Life Sciences is seeking a highly skilled Regulatory Affairs Biologicals Labeling Specialist to join our team.Responsibilities:Develop and maintain regulatory documents to ensure site compliance with USDA regulations.Support regulatory filing submissions with the USDA for...
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Regulatory Affairs Specialist II
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Regulatory Affairs Specialist
3 weeks ago
South Plainfield, New Jersey, United States Katalyst Healthcares & Life Sciences Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Biologicals Labeling Specialist to join our team at Katalyst Healthcares & Life Sciences. As a key member of our regulatory team, you will be responsible for preparing new and revised label packaging for regulatory submissions to the USDA and maintaining regulatory documents to ensure site...
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South Plainfield, New Jersey, United States Katalyst Healthcares and Life Sciences Full time{"title": "Quality Assurance Specialist", "content": "Job SummaryKatalyst Healthcares and Life Sciences is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our medical devices and processes.Key ResponsibilitiesEducation and Experience: Bachelor of...
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