|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 clintrials.gov, 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