Senior Regulatory Affairs Manager

Job Summary

To support the pharmaceutical product lifecycle, the full-time Senior Regulatory Affairs Manager will provide regulatory guidance on labeling and advertising, manage the creation and approval of labeling documents, and ensure compliance with promotional regulations while working remotely.

Key responsibilities

• Provide regulatory guidance on labeling, ad promo, and artwork-related issues to internal teams and external clients
• Manage the creation, review, and approval of labeling documents, including prescribing information and packaging
• Review and approve promotional materials, ensuring alignment with regulatory guidelines and corporate standards

Required qualifications

• Bachelor's degree in a scientific discipline or related field
• Minimum of 10 years of experience in regulatory affairs with a focus on labeling, ad promo, and artwork in the pharmaceutical or biotechnology industry