Senior Regulatory Affairs Specialist

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