Regulatory Operations Specialists

2 weeks ago


Millsboro, Delaware, United States Intelliswift Full time

Qualifications:

Title:
Regulatory Affairs US Biologicals labeling specialist

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.

Preferred/nice to have:
Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology

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.

Note:

  • Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment.

Responsibilities:

  • 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

  • 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

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