Position: Regulatory Affairs Biological Labeling Specialist

Location: Millsboro, DE 19966

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

Duration: 14 months

Job Description:

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 liaise with departments such as Marketing, Pharmacovigilance, and Technical Services to ensure compliance with established regulations.

Must have

· Recent grad with a scientific background- excellent computer skills with ADOBE and office.

· Regulatory labeling content review as per FDA guidelines.

· Quality check of labeling content errors.

· Label artwork, and 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, vaccine 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, and label design review.

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

· Support the team with the review, and revising labeling.

· Attention to detail.

· Will prepare the label content following SOP's and FDA 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

Qualifications:

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 a Bachelor's, a minimum of 0-3 years of relevant experience in pharmaceutical labeling experience.

· With a Master's minimum of 0-2 years of relevant experience in pharmaceutical labeling experience.

· Require someone with a 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, and ADOBE.

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