Regulatory Affairs Senior Associate - Remote

Overview

The Regulatory Affairs Senior Associate role assists in the administration of regulatory strategies for department initiatives across all product brands, focusing on US promotional materials and regulatory documentation.

In Short

• Administers regulatory strategies for US promotional materials.
• Prepares and tracks regulatory documentation.
• Manages label changes and updates.
• Handles Veeva data entry and retrieval.
• Assists with FDA communications and archiving.
• Ensures compliance with promotional regulations.
• Collaborates with cross-functional teams.
• Utilizes MS Office tools for data manipulation.
• Leads video conference meetings.
• Maintains constructive working relationships.

Requirements

• Master’s degree and 4 years of related experience OR Bachelor’s degree and 6 years of related experience.
• Experience with US Regulatory Ad/Promo processes.
• Proficient in Veeva PromoMats and MS Office Suite.
• Strong communication skills.
• Ability to manage documentation and processes effectively.
• Knowledge of FDA eCTD publishing tools.
• Experience in project management.
• Technical editing and proofreading skills.
• Ability to work flexible hours as needed.
• Previous experience in a biopharmaceutical company is preferred.

Benefits

• Opportunities for professional development.
• Work in a leading biotechnology company.
• Collaborative and supportive work environment.
• Flexible working hours to accommodate project needs.
• Commitment to diversity and inclusion in the workplace.