Bryant
Global Manager Regulatory Operations Seqirus Pharmaceuticals at Seqirus Pharmaceuticals
- Role
- Manager Regulatory Operations at Cempra Pharmaceuticals
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Bryant
Result driven Senior Regulatory Operations professional with 19 years pharmaceutical experience, from clinical affairs, to regulatory affairs and regulatory operations.I have had great success in providing regulatory publishing to both Europe, North America and Asia PAC, in both paper and electronic formats. I have successfully led both EU and US teams in the submission of multiple original applications to EU, US, Canadian and International agencies. I have also provided both strategic consulting as well as services to implement, deploy, and put into production both EDMS and eCTD submission publishing systemsSpecialties: Worldwide regulatory submissions: IND, NDA, NDS, EU MAA, CTA, ROW formats.Submission publishing expertise in Insight Publisher, ECTDEXPRESS, DocuBridge ISI Publisher and ISIToolbox.eCTD publishing expertise in ISI eCTDXpress and Liquent InSight Publisher.Provides both strategic consulting as well as services to implement, deploy, and put into production both EDMS and eCTD submission publishing systems
Experience
Manager Regulatory Operations
Feb 2016 — Present
Work to ensure electronic assembly of all submissions are planned, coordinated, and delivered on time and adhere to company and agency standards.Provide ongoing formatting, templates, organizational advice, and guidance for optimal submissions, and ensure quality control and timely preparation of submissions.Initiate, author and collaborate on Standard Operating Procedures, Work Instructions and Workflows for Regulatory Operations.
Skills
- Regulatory Submissions
- U.s. Title 21 Cfr Part 11 Regulation
- CRO Management
- Standard Operating Procedure (Sop)
- CRO
- Regulatory Operations
- Validation
- Documentum
- Nda
- Pharmaceutical Industry
- Sop
- Fda
- U.s. Food and Drug Administration (Fda)
- Ectd
- Gcp
- Clinical Research
- Ctms
- Regulatory Requirements
- Ind
- Clinical Development
- 21 Cfr Part 11
- Clinical Trials
- Protocol
- Regulatory Affairs
- Ich-Gcp
- Document Management
- Good Clinical Practice (Gcp)
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