Regulatory Labeling Specialist

1 week ago


De Soto, Kansas, United States Primary Talent Partners Full time
Primary Talent Partners has a Hybrid, 15-month Contract Regulatory Labeling Specialist opening with a Fortune 100 Pharmaceutical client located at the Desoto, KS site. Pay range is $21 to $26 per hour based on overall experience.

Please note: You will be sitting on a W2 with Primary Talent Partners at an hourly basis without PTO/Benefits - We cannot provide sponsorship or accept C2C, F1 OPT, or 1099 candidates

Position Overview: This position is responsible for the preparation and revision of label packaging for regulatory submissions to the USDA, maintaining regulatory documents to ensure site compliance, and supporting regulatory filing submissions for both domestic and international product packaging. The role involves working independently with internal stakeholders and regulated packaging processes to draft new packaging for vaccine biologicals.

Key Responsibilities:

  • Prepare and revise label packaging for regulatory submissions to the USDA.
  • Maintain regulatory documents to ensure site compliance.
  • Support regulatory filing submissions with the USDA for both domestic and international product packaging.
  • Collaborate with departments such as Marketing, Pharmacovigilance, and Technical Services to ensure compliance with established regulations.
  • Ensure the prompt availability of labels and artworks.

Training Provided:

  • Training on USDA regulations for packaging, ARTIS computer system, and internal processes and workflows for packaging submissions and filing maintenance.
  • Training Type: Corporate Development - Coaching

Qualifications:

  • Title: Regulatory Affairs US Biologicals Labeling Specialist
  • Minimum Education: Associate degree
  • Preferred Education: Bachelor's or Master's degree in Life Science

Required Experience and Skills:

  • With Associate Degree: Minimum 3-5 years of relevant experience within pharmaceutical labeling.
  • With Bachelor's Degree: Minimum 0-3 years of relevant experience within pharmaceutical labeling.
  • With Master's Degree: Minimum 0-2 years of relevant experience within pharmaceutical labeling.
  • Scientific background or familiarity with medical terminology.
  • Excellent proofreading skills.
  • Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, SharePoint, and Adobe.

Preferred/Nice to Have:

  • Experience in the Pharmaceutical Industry, Vaccine Manufacturing, or Medical and Biotechnology sectors.

Additional Information:

  • Hybrid schedule (onsite for 3 days/week: Tuesday and Wednesday fixed, 3rd day can be discussed when on assignment)
  • Note: PhD candidates should not apply.
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at


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