Job Title : Regulatory Operations Specialists - II (Associate)

Location : Millsboro, DE-Hybrid

Duration : 14 Months contract

Pay Rate: $26/hr on w2

Note:

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

Responsibilities:

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

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.

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.

Comments/Special Instructions

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.