Jesse Hovis
- Role
- Associate Director, Regulatory Operations, Vaccines at Takeda
- Location
- Peabody, MA, US
- LinkedIn followers
- 500 followers
Experience
Associate Director, Regulatory Operations, Vaccines
Jul 2021 — Present
RIM (Veeva) • Document and Submission management in Veeva Vault RIM Submissions Module • Business Administrator (Interim Vault Owner) • Business Lead for VBU Veeva Upgrades • Supported Implementation of the Content Planning, Registration Tracking and Submission Archive features in Veeva • Supports Takeda wide integration of VeevaRIM into VBU’s existing platform Submission Support • Plans and supports activities to ensure multi-country Marketing Application (MA) will be submitted in accordance to regional submission standards while meeting corporate deadlines. • Publishing vendor selection and management • Managed Ops activities for Marketing Applications to US, EU (Approved), and Thailand. • Work with LOCs to submit marketing applications to ROW countries (Indonesia Approved) • Manages Ops activities for RTQs for US, EU and several emerging markets • Manages Ops activities for Variations for EU • Oversight of report-level publishing and submission-ready activities in accordance with Takeda standards and regulatory requirements.
Skills
- Regulatory Affairs
- Biotechnology
- Quality Assurance
- Edc
- Regulatory Submissions
- Ectd
- Standard Operating Procedure (Sop)
- Pharmaceutical Industry
- Clinical Research
- Validation
- Electronic Common Technical Document (Ectd)
- Gmp
- Sop
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