Jennifer Villaruz, MS

415-***-**** • https://www.linkedin.com/in/jennifervz • adzap9@r.postjobfree.com

San Francisco, CA

Regulatory Affairs Specialist

AREAS OF EXPERTISE

Regulatory Guidelines:

FDA, EMA, Health Canada, PMDA, ASEAN

Software Applications:

Veeva RIM/ Ad Promo; MS Office Suite; Adobe Acrobat

Document Management Systems:

Migration, Roll Out, Training, Report Generation, Submissions

ECTD Publishing Software:

Global Submit, Insight for Viewing, OmniView, ISI Toolbox, Cloudberry

Other Skills:

Marketing Application Filing, 21 CFR 820, ISO 13485

PROFESSIONAL EXPERIENCE

ALKERMES, INC., – Waltham, MA Oct 2021 – July 2023

Regulatory Operations Manager (Remote)

Developed and maintained relationships with external vendors for eCTD publishing and CTAs.

Managed two market application filings and three initial IND applications from formatting to ESG Gateway submission.

Coordinated AdPromo pieces in Veeva, finalized for publishing, disseminated internally, and archived submission.

Owned Safety Submission processing by working directly with Pharmacovigilance to submit MedWatch(es) to FDA.

Improved workstreams via systems training, work instruction authoring, ad-hoc report generation, and presentations.

Ad-hoc document formatting, report publishing, and submission quality checks.

ADC THERAPEUTICS – San Mateo, CA Apr 2021 – July 2021

Regulatory Operations Manager, CMC (Remote Contract)

Replaced the Regulatory Operations Manager who was on leave of absence.

Gathered data for urgent Health Authority responses by participating in CMC meetings upon request, notifying relevant functions, and adding change data to the submission.

ARCUS BIOSCIENCES, INC. – Hayward, CA Sep 2020 – Mar 2021

Regulatory Operations Manager (Remote)

Developed systems and procedures to improve operational quality and team efficiency for Document Processing.

Formatted and report published M1 – M4 and created/managed workflows in Veeva RIM.

Contributed to authoring the Style Guide.

Managed template content updates by implementing Style Guide structure to M3 StartingPoint templates.

Trained and onboarded all applicable new hires for VVS RIM Authoring and templates.

Assessed the operational impact of new procedures for Reg Strategy by analyzing relevant SOPs in VVS Quality.

PORTOLA PHARMACEUTICALS – South San Francisco, CA June 2019 – Sep 2020

Regulatory Operations Associate

Ran weekly submission meetings to ensure adequate Regulatory Operations resource allocation for submissions.

Coordinated the flow of documents for US and EU submissions.

Managed the relationship with the publishing vendor.

Published and compiled M1-M5.

Owned Safety Submission processing by working directly with Pharmacovigilance to submit MedWatch(es) to FDA.

Maintained Regulatory submission archive and trackers.

FIBROGEN, INC. – San Francisco, CA Feb 2018 – June 2019

Regulatory Operations Associate

Provided regulatory operations support for the first marketing application filing to the CFDA and FDA.

Trained new hires on Document Management Systems 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.

Handled document formatting and contributed to writing the Style Guide.

Managed US and global submission and correspondence trackers.

NEKTAR THERAPEUTICS – San Francisco, CA Aug 2017 – Feb 2018

Regulatory Associate (Contract)

Prepared Regulatory Strategy presentations for combination therapy products that treated multiple indications.

Maintained and managed submission trackers and Safety Reports with CROs.

Maintained and archived regulatory submissions and correspondence.

Performed troubleshooting of publishing tool errors with the vendor as needed.

Conducted and documented quality control checks to maintain compliance with company initiatives.

ROCHE / GENENTECH – San Francisco, CA Aug 2015 – June 2017

Regulatory Specialist (Contract) / Regulatory CMC (Aug 2016 – June 2017)

Assistant Regulatory Specialist (Contract) / Regulatory CMC (Aug 2015 – Aug 2016)

Coordinated the flow of documents for submission generation of CMC dossiers such as HA Responses, INDs, IMPDs, NDAs, BLAs, and Prior Approval Supplements.

Formatted submission sections using MS Word templates and style guidelines.

Prepared PDF 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 on internal stakeholders.

Recommended improvements to processes which improved alignment across global Roche sites.

Worked with governance committees to make and evaluate plans.

EDUCATION

M.S., Regulatory Affairs and Health Policy 2023

Massachusetts College of Pharmacy and Health Sciences, Boston, MA

GPA: 3.70

B.A., Communications, Journalism 2006

University of Washington, Seattle, WA

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