Global Regulatory Labeling Specialist (Contract)

Artech Information System LLC; Swiftwater (Monroe County); On-site; USD 90,000 - 120,000; Full time

Job summary

A staffing and consulting organization is seeking a Global Regulatory Affairs Labeling Associate to ensure compliance with labeling processes. The role includes leading the preparation of a United States Package Insert and contributing to the Quality Enhancement Plan. The ideal candidate will have 4-8 years of relevant experience and a Bachelor's degree in a scientific field. This position requires effective collaboration with multiple departments for accurate labeling documentation.

Qualifications

• 4-8 years of prior Regulatory Affairs or relevant industry experience.
• Demonstrated experience with biopharmaceuticals.
• Business Certification and/or experience preferred.

Responsibilities

• Ensure adherence to local and global labeling processes.
• Lead and write a United States Package Insert (USPI).
• Participate in scientific and technical exchanges with various departments.

Skills

Regulatory Affairs experience

Biopharmaceuticals knowledge

Management capability

Business Certification

Communication skills

Education

Bachelor's degree in scientific field

Advanced degree

Job description

A staffing and consulting organization is seeking a Global Regulatory Affairs Labeling Associate to ensure compliance with labeling processes. The role includes leading the preparation of a United States Package Insert and contributing to the Quality Enhancement Plan. The ideal candidate will have 4-8 years of relevant experience and a Bachelor's degree in a scientific field. This position requires effective collaboration with multiple departments for accurate labeling documentation.