Job Title: Regulatory Affairs US Biologicals labeling specialist

Location: Millsboro, DE 19966 (Hybrid)

Duration: 12+ Months (Extendable)

Pay Rate: $39.45/hr. on W2

POSITION OVERVIEW:

• Regulatory labeling content review as per FDA guideline.

• Quality check of labeling content errors.

• Label artwork, label design review.

• Support the preparation of labeling documents, coordinating labeling document submissions to regulatory bodies.

• Looking for someone with labeling expertise in the pharmaceutical industry, vaccines manufacturing or GMP.

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 5-7 years of relevant experience within pharmaceutical labeling experience.

• With Bachelor's, minimum 4-6 years of relevant experience within pharmaceutical labeling experience.

• With Master's minimum 2-5 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.

Must have:

• Regulatory labeling content review as per FDA guideline.

• Quality check of labeling content errors.

• Label artwork, label design review.

• Support the preparation of labeling documents, coordinating labeling document submissions to regulatory bodies.

• Looking for someone with labeling expertise in the pharmaceutical industry, vaccines manufacturing or GMP.

Typical day:

• Very intensive label-oriented job

• Need someone to hit the ground running.

• Label review and submission of labeling documents and artwork

• Label artwork, label design review.

• Quality check for label content and formatting as per FDA guidelines.

• Support the team with the review, revising labeling.

• Attention to details.

• Will prepare the label content following SOP’s and FDA regulations.

Responsibilities:

This position is responsible but is not limited to the following duties:

• 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