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Jennifer Villaruz Email & Phone Number
Regulatory Manager
at
Connect Biopharma
LinkedIn matched
✓ Verified May 2026
3 data sources
Profile completeness 86%
Current company
Role
Regulatory Manager
Location
San Francisco, California, United States
Who is Jennifer Villaruz? Overview
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Jennifer Villaruz is listed as Regulatory Manager at Connect Biopharma, based in San Francisco, California, United States. AeroLeads shows a matched LinkedIn profile for Jennifer Villaruz.
Jennifer Villaruz previously worked as Gap year at Career Break and Regulatory Operations Manager at Alkermes. Jennifer Villaruz holds Master Of Science - Ms, Regulatory Affairs And Health Policy (Drugs, Medical Devices, & Biologics) from Massachusetts College Of Pharmacy And Health Sciences.
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Email format at Connect Biopharma
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Connect Biopharma
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Profile bio
About Jennifer Villaruz
Regulatory professional with 10 years of experience, looking for a long-term role with an established company. Adept at navigating regulatory guidelines and the technical systems that manage data for Health Authority interactions and regulatory decision-making. Leveraging experience with submission management and RIM, I have been acknowledged as an effective collaborator, always ensuring dossier consistency, timely submission delivery, and audit readiness. I would be particularly interested in expanding my experience with vendor management.My professional values are focused on accountability, respect for people, and continuous learning.
Current workplace
Jennifer Villaruz's current company
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8 roles
Jennifer Villaruz work experience
A career timeline built from the work history available for this profile.
Gap Year
Current
Career Break
Sep 2023 - Present
Regulatory Operations Manager
Leadership⦁ Tracked and managed eCTD submission content plans.⦁ Led routine RA submissions for assigned INDs, NDAs, and DMFs.⦁ Took initiative by providing impactful OPDP Warning Letters to AdPromo.⦁ Developed and maintained vendor relationships for publishing.⦁ Performed US and international regulatory research and intelligence (Masters program).⦁ Guided.
Oct 2021 - Jul 2023
Regulatory Manager - Operations Cmc
⦁ Participated in HA questions/queries for CMC by collaborating cross-functionally to change acceptance criteria forsafety data.⦁ Improved RO formatting, versioning, and life-cycling standards.
Apr 2021 - Jul 2021
Regulatory Operations Manager
Project Management⦁ Implemented the Veeva RIM collaborative authoring workflow.⦁ Assessed the operational impact of new procedures for Reg Strategy by analyzing relevant SOPs.⦁ Successfully implemented the first initial IND authored in RIM.⦁ Tracked and managed eCTD submission content plans.Process Improvement⦁ Created EMA and OUS submission workflows in.
Sep 2020 - Apr 2021
Regulatory Operations
Portola Pharmaceuticals Jun 2019 – Sep 2020Fibrogen, Inc. Feb 2018 – Jun 2019 Nektar Therapeutics Aug 2017 – Feb 2018Regulatory OperationsLeadership⦁ Managed vendor relationships. ⦁ Led weekly team meetings to ensure proper resources were allocated for upcoming submissions.⦁ Trained new hires in Document Management Systems and RO workstreams.⦁ Collaborated.
Aug 2017 - Sep 2020
Regulatory Affairs Specialist
Project Management⦁ First experience with marketing submissions (NDA and BLA).Process Improvement⦁ Served as US counterpart for global technical tool generation.⦁ Recommended features for new DMS (IDM) to Leadership.General⦁ Coordinated the flow of CMC submissions.⦁ Format, compiled, and report-published submissions for US, HC, and EU. ⦁ Provided training.
Jul 2016 - May 2017
Assistant Regulatory Affairs Specialist
Aug 2015 - Jul 2016
3 education records
Jennifer Villaruz education
Master Of Science - Ms, Regulatory Affairs And Health Policy (Drugs, Medical Devices, & Biologics)
Massachusetts College Of Pharmacy And Health Sciences
Bachelor Of Arts - Ba, Communication, Journalism, And Related Programs
University Of Washington
Associate Of Arts - Aa
Highline College
FAQ
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Quick answers generated from the profile data available on this page.
What company does Jennifer Villaruz work for?
Jennifer Villaruz works for Connect Biopharma.
What is Jennifer Villaruz's role at Connect Biopharma?
Jennifer Villaruz is listed as Regulatory Manager at Connect Biopharma.
Where is Jennifer Villaruz based?
Jennifer Villaruz is based in San Francisco, California, United States while working with Connect Biopharma.
What companies has Jennifer Villaruz worked for?
Jennifer Villaruz has worked for Connect Biopharma, Career Break, Alkermes, Adc Therapeutics, and Arcus Biosciences.
How can I contact Jennifer Villaruz?
You can use AeroLeads to view verified contact signals for Jennifer Villaruz at Connect Biopharma, including work email, phone, and LinkedIn data when available.
What schools did Jennifer Villaruz attend?
Jennifer Villaruz holds Master Of Science - Ms, Regulatory Affairs And Health Policy (Drugs, Medical Devices, & Biologics) from Massachusetts College Of Pharmacy And Health Sciences.
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