- Remote
- Remote
- Senior
- $165K–$209K per year
Manage and independently execute regulatory submission planning, publishing, quality control, delivery, archiving and lifecycle management for clinical and commercial programs.
Compensation
Range for this position: $165,000 - $208,500
Responsibilities
- Independently format, publish, transmit and archive Health Authority submission types, ensuring submissions are high quality, compliant and delivered according to established timelines.
- Serve as subject matter expert for regulatory publishing and document management technologies such as LORENZ docubridge, Veeva Vault RIM, Microsoft Word, Adobe Acrobat and regulatory validation tools, as applicable.
- Provide Regulatory Operations expertise and guidance on eCTD structure, content readiness, publishing requirements, validation, dispatch and lifecycle management in accordance with Health Authority requirements.
- Perform document- and submission-level technical quality control to ensure completeness, consistency, accuracy and compliance with company standards and regulatory requirements.
- Identify IT solutions to enhance Regulatory Operations capabilities in document formatting and submission publishing, automation opportunities and technology enhancements that improve submission quality, efficiency, compliance and scalability.
Requirements
- Bachelor’s degree in related discipline and a minimum of nine years of related experience