Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Senior Regulatory Affairs Specialist - Pharma (Remote).

Key Responsibilities:

• Oversee end-to-end dossier execution activities including submission planning and execution throughout a product's lifecycle
• Collaborate with Regulatory Leads and cross-functional content authors to develop and maintain submission content plans
• Provide input and guidance on submission processes, compliance, and deliverables as a Regulatory Operations representative

Required Qualifications:

• Bachelor's degree or equivalent work experience
• 7+ years of Regulatory Operations experience in pharmaceutical drug development and global submissions
• 3+ years of eCTD publishing experience
• Demonstrated expertise with eDMS applications and publishing systems
• Knowledge of 21 CFR Part 11 compliance and software/system validation