Liam Curran
Regulatory Information Management
- Role
- Director, Regulatory Information Systems at Ascendis Pharma
- Location
- Palo Alto, CA, US
- LinkedIn followers
- 500 followers
About Liam Curran
Spanning more than 25 years of experience in industry I have built competencies to drive…
Experience
Director, Regulatory Information Systems
Jan 2022 — Present · Palo Alto, CA, US
Responsible for strategic, operational, and business support for Ascendis Pharma’s Regulatory Information Management (RIM) platform, in close partnership with the IT and Regulatory groups• Serve as RIM Subject Matter Expert for Regulatory technology strategy• Provide Regulatory system and data related business support, implementation, and change management• Engage with business process owners, stakeholders, vendors, IT colleagues, and others as necessary to define system issues, resolutions and opportunities• Maintain a current understanding of industry expectations for system management and ensure that they are reflected in any technical strategy and business changes accordingly• Support data integration, data quality and the development of data governance standards to facilitate reporting and business decision making• Partner with industry organisations and health authorities to influence outcomes relating to emerging requirements such as ISO IDMP• Coordinate cross-functional technology awareness and education sessions• Provide strategic updates and guidance to the Regulatory Affairs Senior Leadership Team as well as petitioning for endorsement of new initiatives• Serve as a key member of the Regulatory Operations team, helping to identify, propose, develop and manage improvement projects
Education
University of Arizona
Molecular and Cellular Biology, Physics
1992 — 1998
Skills
- Cross-Functional Team Leadership
- Biotechnology Industry
- Regulatory Affairs
- Clinical Trials
- Quality Assurance
- Ectd
- Microsoft Office
- Good Clinical Practice (Gcp)
- Change Management
- Life Sciences
- Global Regulatory Submissions
- Corrective and Preventive Action (Capa)
- Custom Templates
- Change Control
- Regulatory Submissions
- Team Leadership
- Leadership
- Biotechnology
- Business Development
- Research
- Strategy
- Gxp
- Quality Control
- Project Management
- Pharmaceutics
- Business Strategy
- Computer System Validation
- Quality System
- Document Management
- Pharmaceutical Industry
- Business Process Improvement
- Fda
- Strategic Planning
- Documentum
- Standard Operating Procedure (Sop)
- Enterprise Content Management
- Management
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