What are the responsibilities and job description for the Regulatory Labeling Specialist - RLS 25-19531 position at NavitsPartners?
Title: Regulatory Labeling Specialist
Duration: 12 Months
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:
Minimum Education: Associate degree required.
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.
