Regulatory Affairs US Biologicals Labeling Specialist

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

Note:
• Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment.
• DO NOT submit PHD.

Responsibilities:
Merck 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.