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Regulatory Affairs Biologicals labeling specialist

Remote:

Full Remote

Experience:

Mid-level (2-5 years)

Work from:

Connecticut (USA), Illinois (USA)

Offer summary

Qualifications:

3-5 years Associate experience in pharmaceutical labeling, Bachelor's, scientific background, proofreading skills, Proficiency in standard computer programs.

Key responsabilities:

Prepare label packaging for regulatory compliance submissions
Support regulatory filing submissions with USDA
Independently work on revising/drafting new packaging
Ensure prompt availability of labels/artworks and liaise for compliance

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

Animal Health is a Biotechnology Center of Excellence that manufactures, fills, packages, and distributes vaccines for animals.
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.

Requirements:

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.