Regulatory Labeling Specialist - RLS 25-19531

Location: Millsboro, DE (Hybrid – Onsite 3 Days/Week)

Responsibilities:

• Prepare new and revised label packaging for regulatory submissions to the USDA.
• Maintain regulatory documents to ensure site compliance.
• Support regulatory filing submissions for both domestic and international product packaging.
• Collaborate with internal stakeholders to revise or draft new packaging for vaccine biologicals.
• Ensure timely availability of labels and artworks while coordinating with Marketing, Pharmacovigilance, and Technical Services to maintain compliance with regulations.
• Train on USDA packaging regulations, ARTIS computer system, and internal processes for packaging submissions.

Qualifications:

Preferred Education: Bachelor’s/Master’s degree in Life Sciences.

Required Experience & Skills:

• With Associate: Minimum 5-7 years of pharmaceutical labeling experience.
• With Bachelor’s: Minimum 4-6 years of pharmaceutical labeling experience.
• With Master’s: Minimum 2-5 years of pharmaceutical labeling experience.
• Background in science or familiarity with medical terminology.
• Strong proofreading skills.
• Proficiency in Microsoft Office (Excel, Word, Outlook), SharePoint, and Adobe.

Preferred Experience:

• Experience in pharmaceutical, vaccine manufacturing, or biotechnology industries.

Key Competencies:

• High attention to detail.
• Strong team player with the ability to work independently after training.
• Ability to ensure compliance with regulatory guidelines.
• Excellent communication and written skills.
• Open-minded and adaptable.

Must-Have Skills:

• Regulatory labeling content review per FDA guidelines.
• Quality checks for labeling content errors.
• Label artwork and label design review.
• Preparation and submission of labeling documents to regulatory bodies.
• Expertise in pharmaceutical labeling, vaccine manufacturing, or GMP.

Typical Day:

• Intensive label review and submission work.
• Ensuring accuracy and compliance with FDA and USDA regulations.
• Supporting label revisions and quality checks.
• Preparing label content following SOPs and regulatory guidelines.