Responsibilities:Global Regulatory Affairs: Stay current with global regulatory guidelines. Research requirements for pharmaceutical, biologic, and tobacco submissions across the world.Knowledge Base: Collaborate with lead publishers to build and maintain Aquila Solutions’ knowledge base. Create, maintain, and update documentation for regulatory information systems.Regulatory Publishing: Prepare and submit eCTD and non-eCTD electronic submissions to regulatory authorities.Systems Analysis & Maintenance: Evaluate information systems to ensure they are appropriate, well-understood, and well-utilized. Develop and submit proposals for new systems and maintain existing systems.Systems Implementation & Testing: Develop and execute test plans for new information systems under development. Facilitate a seamless, company-wide transition to newly implemented information systems.

Responsibilities:Document Formatting: Performed the QC on electronic documents and formatted them to meet regulatory submission guidelines.Regulatory Publishing: Built eCTD sequences, including complete CTA and IND applications, for submission to regulatory authorities.Research: Conducted background research on the guidance and regulations from the FDA, Health Canada, and EMA in order to keep the organization up to date with the latest guidelines and standards.Structured Product Labeling: Wrote and reviewed SPL for prescription and over-the-counter labeling.Teamwork: Kept effective communication with support staff while meeting project deadlines and requirements.

Responsibilities:Document Formatting: Performed the QC on electronic documents and formatted them to meet regulatory submission guidelines.Research: Conducted background research on the guidance and regulations from the FDA, Health Canada, and EMA in order to keep the organization up to date with the latest guidelines and standards.Structured Product Labeling: Reviewed SPL for prescription and over-the-counter labeling.