Monica Reckless
Regulatory Affairs Manager/Quality NDA, IND & PMA Submissions/Lifecycle Management
- Role
- AstraZeneca
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Monica Reckless
Over 17 years experience in the Regulatory Field. Experienced In the creation,submission…
Experience
Present
Skills
- Gcp
- Adobe Acrobat
- Management
- Sharepoint
- Pharmaceutical Industry
- Regulatory Affairs
- Clinical Trials
- Research
- CRO
- Regulatory Submissions
- Sop
- Software Documentation
- Quality Assurance
- Fda
- Clinical Research
- Edc
- Ctms
- Microsoft Office
- Oncology
- Medical Writing
- Ind
- Regulatory Requirements
- Ich-Gcp
- 21 Cfr Part 11
- Nda
- Pharmaceutics
- Medical Devices
- Gxp
- Drug Development
- Ectd
- Therapeutic Areas
- Document Management
- Documentum
- Regulatory Documentation
- Regulations
- Anda
- Lifesciences
- Clinical Development
- Validation
- Cross-Functional Team Leadership
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