Job Description Senior Manager, Regulatory Operations

The Regulatory Operations Senior Manager is responsible for management, preparation, quality assurance, and filing of regulatory submissions through health agencies worldwide in accordance with agency requirements and company standards.
• Planning and building paper and electronic submissions to various global Regulatory Agencies, in compliance with Health Authority requirements.
• Perform quality assurance of submissions for completeness and correctness in formatting and navigation.
• Work with authors to provide regulatory operational advice on document preparation and formatting
• Maintain in house repository for archiving regulatory submissions and Health Authority correspondence
• Responsible for Documents and Records Management, includes Clinical Trials on, documents within the Virtual Data Room, references submitted to agencies, and internal documentation.

• Bachelor’s degree or equivalent in life sciences or technology-related discipline.
• Minimum of 7 years of pharmaceutical industry experience.
• Complete lifecycle regulatory submission publishing and document management experience required. Knowledge in eCTD, (IND, NDA, NDS, CTA) preferred
• Proficient in Microsoft Windows environment including, but not limited to, Microsoft Office products; Adobe Acrobat and plug-ins; document management systems; publishing product lines.
• Employs advanced troubleshooting techniques to efficiently address publishing tool issues. Ability to learn new technology and apply to business needs