Ashley Dynan Email & Phone Number
Senior Director of Regulatory Affairs @ APIJECT LIMITED
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Ashley Dynan Location
- Denver, CO, US
Ashley Dynan Work
- Senior Director of Regulatory Affairs @ (April 2023 - Present)
- Director of Regulatory Affairs @ (July 2021 - February 2023)
- Principal Regulatory Affairs Consultant @ (July 2021 - February 2022)
- Global Manager of Regulatory Affairs @ (August 2019 - July 2021)
- Quality and Regulatory Affairs Manager @ Bellus Medical (November 2016 - July 2019)
- Quality Engineer- Advanced Energy @ (November 2015 - September 2016)
- Sr. Quality Systems Specialist @ (May 2014 - November 2015)
- Compliance Specialist- Neurovascular Division @ (January 2013 - May 2014)
- Quality Assurance and Compliance Supervisor @ (January 2012 - January 2013)
- Quality Systems Analyst @ (January 2011 - January 2012)
- Quality Assurance and Compliance Specialist @ (January 2010 - February 2011)
- Clinical Services Coordinator II @ (March 2009 - July 2010)
- Quality Assurnace and Regulatory Coordinator @ (January 2007 - January 2008)
Ashley Dynan Skills
- CMC Regulatory Affairs
- Compliance Regulations
- Quality Management
- Continuous Improvement
- Due Diligence
- Global Regulatory Compliance
- Auditing
- Team Leadership
- Quality Assurance
- Organizational Effectiveness
- Compliance
- Internal Audit
- Close Attention to Detail
- Team-oriented
- Collaborative Work
- ISO 13485
- FDA GMP
- CAPA
- Organizational Development
- Process Improvement
- Time Management
- Multi Tasking
- Regulatory Affairs
- Laboratory
- Trackwise
- GxP
- LIMS
- GLP
- V&V
- Biotechnology
- GMP
- Medical Devices
- Quality System
- Standard Operating Procedure (SOP)
- U.S. Food and Drug Administration (FDA)
- Design Control
- ISO 14971
- Premarket Approval (PMA)
- Regulatory Submissions
- Commercialization
- cGMP manufacturing
- Batch Records
- English
- Batch Release
- New Drug Application (NDA)
- NCMR
- MDR
- ISO Standards
- Root Cause Analysis
- Failure Mode and Effects Analysis (FMEA)
- Project Management
- 510k
- Leadership
- CE marking
- Certified Quality Auditor (CQA)
Ashley Dynan Summary
- Ashley Dynan, based in Denver, CO, US, is currently a Senior Director of Regulatory Affairs at ApiJect. Ashley Dynan brings experience from previous roles at Network Partners, AlloSource® and Bellus Medical. With a robust skill set that includes CMC Regulatory Affairs, Compliance Regulations, Quality Management, Continuous Improvement, Due Diligence and more. Ashley Dynan has 5 emails and 2 mobile phone numbers on RocketReach.
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