Nancy Watts
The cosmos is within us. We are made of star-stuff. We are a way for the universe to know itself. - Carl Sagan
- Role
- Associate Director Regulatory Affairs at IQVIA
- Location
- Hamilton, OH, US
- LinkedIn followers
- 500 followers
About Nancy Watts
Beginning as an Analytical Chemist, my career path swiftly expanded into pharmaceutical, medical device and clinical research regulatory compliance, GMP/GCP process improvement and project leadership. I received my Regulatory Affairs Certification (RAC) through RAPS and provide consulting services for clients ranging from Quality management to Regulatory Strategy and Submissions. As a consultant, I have been privileged to support a variety of clients, including CROs, Pharmaceutical and Medical Device manufacturers, Regulatory Intelligence teams and outsourcing establishments within the industry. My recent experience includes Regulatory intelligence, safety evaluation, investigations, FDA correspondence, MDR and Regulatory support for Biologics and Class Medical Device manufacturers, along with project leadership and consulting for major Fortune 500 clients. I look forward to working with your quality and regulatory affairs teams to ensure consistent and efficient regulatory compliance. My focuses include project management, regulatory strategy and compliance, PV support, inspection, training, technical writing, risk evaluation, and quality data review. My goals include:1) Supporting pharmaceutical and medical device industry clients with regulatory intelligence and strategy2) Quality pharmaceutical and medical device development, production, data reporting and agency communication.3) Developing processes to ensure efficacy and safety of clinical and marketed products4) Continuing improvements to ensure compliance with US Federal and International regulationsSpecialties: ICH Clinical Research and Quality guidelines, FDA regulations, Regulatory Affairs, Quality Assurance, Analytical Chemistry, Inspections, Validation, Pharmaceuticals and Medical Device, Project coordination and documentation
Experience
Associate Director Regulatory Affairs
Oct 2022 — Present · Durham, NC, US
As a leader within the Real World Solutions global business unit, I support clients with RWE projects including interventional and observational studies from initiation through close-out. Along with independent oversight for pharmaceutical and medical device regulatory programs involving complex regulatory/technical deliverables, strategic regulatory/technical consultancy and reporting. My goals focus on patient centered research, clinical and post-market product advancement, RWE study strategy, health authority compliance and communication, and post-market pharmacovigilance.
Education
Ohio University
Bachelor of Science, Chemistry, Forensic
1994 — 1999
Skills
- Analytical Chemistry
- Document Review
- Medical Devices
- Clinical Research
- Capa
- Apis
- Uv/Vis
- U.s. Food and Drug Administration (Fda)
- Quality Auditing
- Training
- Chemistry
- Laboratory
- Change Control
- Gcp
- Regulatory Affairs
- V&V
- Regulatory Compliance
- Technical Writing
- Clinical Trials
- Glp
- Dissolution
- Biotechnology
- Sop Development
- Lims
- Change Management
- CRO
- Investigation
- Wet Chemistry
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Submissions
- Hplc
- Project Coordination
- Quality Assurance
- Api
- Standard Operating Procedure (Sop)
- Pharmaceutical Research
- Validation
- Quality Control
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