Jennifer Villaruz
San Francisco,CA
Summary
To seek a position that offers professional challenges that allow for interpersonal skills, a natural curiosity, and growth opportunities. The ideal role will allow me to bridge over from Regulatory Operations to Regulatory Strategy, utilizing previous experience while expanding on the knowledge I've achieved from recent completion of an MS in Regulatory Affairs and Health Policy.
Overview
6
6
years of professional experience
Work History
Regulatory Operations Manager, CMC
ADC Therapeutics, Real Staffing
04.2021 - 07.2021
- Fill in for RO manager on leave.
- Gathered data for urgent HA responses.
Regulatory Operations Manager
Arcus Biosciences, Inc
09.2020 - 03.2021
- Developed systems and procedures to improve operational quality and team efficiency for Document Processing.
- Formatted and report published M1 – M4 in VVS RIM.
- Document formatting and contribution to Style Guide.
- Managed template content updates.
- Trained and onboarded all applicable new hires for VVS RIM Authoring and templates.
- Analyzed and assessed operational impact of new procedures.
Regulatory Operations Associate
Portola Pharmaceuticals
06.2019 - 09.2020
- Ran weekly submission meeting to ensure adequate Reg Ops resource allocation.
- Coordinated flow of documents for US and EU submissions.
- Manage relationship with publishing vendor.
- Pre-published reports.
- Processed Safety Reports.
- Support of process improvement efforts.
- Maintain Regulatory submission archive and trackers.
Regulatory Operations Associate
FibroGen Inc
02.2018 - 08.2018
- Provided regulatory operations support for first marketing application filing to CFDA and FDA.
- Trained new hires on Document Management System and Regulatory processes.
- Published submissions using Global Submit through ESG Gateway.
- Pre-published M4-M5 reports; QC of submission errors.
- Migrated all submissions and correspondences into DMS (RIM).
- Authored Work Instructions and SOPs.
- Document formatting and contribution to authoring Style Guide.
- Management of US and global submission and correspondence trackers.
Regulatory Associate (temp)
Nektar Therapeutics
08.2017 - 02.2018
- Preparation of Regulatory Strategy presentations for combination therapy products that treat multiple indications.
- Maintained and managed submission trackers and Safety Reports with CROs.
- Maintained and archived regulatory submissions and correspondences.
- Troubleshoot publishing tool errors with vendor as needed.
- Performed and documented quality control checks to maintain compliance with company initiatives.
Regulatory Specialist (contract), Regulatory CMC
Roche-Genentech
08.2016 - 06.2017
- Coordinated flow of documents for submission generation of CMC dossiers such as HA Responses, INDs, IMPDs, NDAs, BLAs, PAS variations.
- MS Word document formatting of submission sections via template and style guidelines.
- PDF preparation by checking bookmarks, links, document info, catalog indices, and pagination.
- Provided training for Document Management System, Publishing platform, and SharePoint.
- Analyzed new regulatory requirements, regulations, rules, or recommendations and advised potential impact to internal stakeholders.
- Recommended improvements to processes which improved alignment across global Roche sites.
- Worked with governance committees to make and evaluate plans.
Assistant Regulatory Specialist (contract)
Regulatory CMC, Roche-Genentech
08.2015 - 08.2016
Education
M.S - Regulatory Affairs and Health Policy
Massachusetts College of Pharmacy And Health Sciences
Boston, MA2023
B.A. - Communication – Journalism
University of Washington
Seattle, WA2006
Skills
- Regulatory guidelines and submissions - FDA, EMA, Health Canada, PMDA, ASEAN
- Marketing application filing
- ECTD Submission Publishing – Global Submit, Insight for Viewing, OmniView, ISI Toolbox, Cloudberry
- Document Management Systems – training, roll-out, report generation, submission adjudication, migration
- Microsoft Office Suite with proficiency in Word
- Adobe Acrobat
Timeline
Regulatory Operations Manager, CMC
ADC Therapeutics, Real Staffing
04.2021 - 07.2021
Regulatory Operations Manager
Arcus Biosciences, Inc
09.2020 - 03.2021
Regulatory Operations Associate
Portola Pharmaceuticals
06.2019 - 09.2020
Regulatory Operations Associate
FibroGen Inc
02.2018 - 08.2018
Regulatory Associate (temp)
Nektar Therapeutics
08.2017 - 02.2018
Regulatory Specialist (contract), Regulatory CMC
Roche-Genentech
08.2016 - 06.2017
Assistant Regulatory Specialist (contract)
Regulatory CMC, Roche-Genentech
08.2015 - 08.2016
M.S - Regulatory Affairs and Health Policy
Massachusetts College of Pharmacy And Health Sciences
B.A. - Communication – Journalism
University of Washington
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