Manager, Regulatory Operations
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Job Description
Manager of Regulatory Operations leading submission activities in a biopharmaceutical company focused on hypertension and related diseases.
Responsibilities:
- Support regulatory operations and publishing activities, including internal coordination and vendor management, to achieve on-time delivery.
- Coordinate, compile, format, and publish regulatory submissions (e.g., IND/CTA, NDA/MAA, variations, amendments) as needed, ensuring technical compliance with applicable authority requirements.
- Manage quality control reviews of submission deliverables, ensure conformance with company standards, RIM metadata requirements, and regulatory guidelines.
- Coordinate sequencing and gateway testing for electronic filings, resolve technical submission errors and regulatory agency technical requests.
- Drive best practices in document lifecycle management, including version control, archival, and audit preparedness.
- Help maintain and optimize regulatory operations infrastructure, including RIM, templates, and workflow SOPs and WIs.
- Establish and maintain submission and regulatory correspondence trackers, dashboards, and metrics for organizational visibility and audit readiness.
- Drive continuous improvement of regulatory operations processes for efficiency, consistency, and audit readiness.
- Monitor updates to electronic submission standards and implement required changes to processes and tools.
- Interface with Regulatory Affairs, Non-clinical, Clinical, CMC, Quality, and IT etc. to align operational requirements with content strategy and submission timelines.
- Coordinate with internal and external stakeholders (e.g., contractors, publishing vendors) to deliver on operational objectives, quality, and timelines.
- Support readiness for health authority inspections of submission practices and document repositories.
- Assist training in regulatory operations systems, methodologies, requirements and best practices.
Requirements:
- Bachelor’s or advanced degrees in Life Sciences, Regulatory Affairs, or related discipline.
- 3 + years of regulatory operations/submissions experience in pharmaceutical or biotech environments, including hands-on publishing and RIM usage.
- Demonstrated knowledge of electronic submission standards (eCTD), metadata, and global regulatory requirements.
- Strong project management, organization, and attention to detail.
- Ability to manage competing deadlines, and work in fast-paced, small-company environment.
- Excellent communication and influencing skills, able to effectively partner with cross-functional teams and external stakeholders.
- Ability to drive process improvements and implement new technologies.
Benefits:
- standard Company benefits including medical, dental, vision, time off and 401K
- participating in Mineralys incentive plans are contingent on achievement of personal and company performance
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