labeling specialist/ Regulatory Operations Specialist

Position: Regulatory Affairs US Biologicals labeling specialist (Regulatory Operations Specialists - II (Associate)

Location: Millsboro, DE,19966

Duration: 12 Months

Note:

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

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

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 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

Must haves:

· 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.