We are seeking a Biologicals Labeling Specialist to join our dynamic team! In this role, you will play a crucial role in ensuring regulatory compliance for our vaccine products by preparing new/revised labeling for US and international submissions. You will work independently and collaboratively to draft accurate and compliant labeling for packaging, liaise with internal stakeholders, and maintain regulatory documents.

Responsibilities and Duties:

• Develop and revise labeling for vaccine biological packaging according to USDA regulations for both domestic and international markets.
• Support the preparation of regulatory filing submissions for packaging to the USDA.
• Conduct thorough quality checks to ensure label content accuracy and formatting adhere to FDA guidelines.
• Collaborate with various departments (e.g., R&D, Quality Assurance) to maintain compliance with established regulations.
• Demonstrate excellent proofreading skills to identify and rectify any errors in labeling content and formatting.

Qualifications:

• Minimum: Associate's degree and 3-5 years of relevant experience in pharmaceutical labeling.
• Preferred: Bachelor's/Master's degree in Life Sciences and experience in the Pharmaceutical Industry, Vaccine manufacturing, or Medical/Biotechnology.
• Strong scientific background or familiarity with medical terminology.
• Excellent written and verbal communication skills with a focus on clarity and accuracy.
• Meticulous attention to detail, ability to work independently, and strong teamwork skills.
• Open-minded and committed to ensuring all regulatory requirements are met.