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Regulatory Affairs US Biologicals labeling specialist

4 months ago

Rehoboth Beach, United States NavitsPartners Full time

Position: Regulatory Affairs US Biologicals labeling specialist 
Location:  Millsboro, DE
Duration: 12 Months

Job Description

Client Animal Health, a Biotechnology Center of Excellence specializing in vaccines for animals, seeks a Regulatory Affairs US Biologicals Labeling Specialist. This role is pivotal in preparing and maintaining regulatory submissions related to labeling packaging for vaccines, ensuring compliance with USDA regulations for domestic and international markets.

Key Responsibilities

  • Labeling and Packaging Preparation:

    • Prepare new and revised label packaging for regulatory submissions to USDA.
    • Maintain regulatory documents to ensure site compliance with labeling requirements.

  • Regulatory Submissions:

    • Support regulatory filing submissions to USDA for both domestic and international product packaging.

  • Collaboration and Compliance:

    • Work independently with internal stakeholders (Marketing, Pharmacovigilance, Technical Services) to revise or draft new packaging for vaccine biologicals.
    • Ensure prompt availability of labels and artworks, ensuring compliance with regulatory standards.
Qualifications

Minimum Education:

  • Associate degree

Preferred Education:

  • Bachelor's or Master's degree in Life Science

Required Experience and Skills:

  • Associate degree: 3-5 years of relevant experience in pharmaceutical labeling
  • Bachelor's degree: 0-3 years of relevant experience in pharmaceutical labeling
  • Master's degree: 0-2 years of relevant experience in pharmaceutical labeling
  • Scientific background or familiarity with medical terminology required
  • Excellent proofreading skills
  • Proficiency in Microsoft Office (Excel, Word, Outlook), SharePoint, Adobe Acrobat

Preferred/Nice to Have:

  • Experience in Pharmaceutical Industry, Vaccine Manufacturing, Medical and Biotechnology sectors
Personality Traits
  • Attention to detail
  • Team player
  • Able to follow directions
  • Independent worker post-training completion
  • Ensures regulatory compliance
  • Excellent communication and written skills
  • Open-minded
Must-Have Skills
  • Regulatory labeling content review per FDA guidelines
  • Quality check of labeling content errors
  • Label artwork and design review
  • Support preparation of labeling documents and submissions to regulatory bodies
  • Labeling expertise in pharmaceutical industry, vaccines manufacturing, or GMP environment
Typical Day
  • Focus on label-oriented tasks
  • Intense label review and submission of labeling documents and artwork
  • Quality check for label content and formatting as per FDA guidelines
  • Support team with labeling revisions and reviews
  • Adherence to SOPs and FDA regulations in label content preparation