Head Regulatory Operations - Pharma
Sep 2019 - Dec 2024
AeroLeads people directory · profile
Jonathan Thibault Email & Phone Number
Head Regulatory Operations - Pharma at Fresenius Medical Care
1 work email found
@fmc-na.com
2 phones found area 617
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 86%
Role
Head Regulatory Operations - Pharma at Fresenius Medical Care
Location
Greater Boston, United States, United States
Who is Jonathan Thibault? Overview
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Quick answer
Jonathan Thibault is listed as Head Regulatory Operations - Pharma at Fresenius Medical Care based in Greater Boston, United States, United States. AeroLeads shows a work email signal at fmc-na.com, phone signal with area code 617, and a matched LinkedIn profile for Jonathan Thibault.
Jonathan Thibault previously worked as Head Regulatory Operations - Pharma at Fresenius Medical Care and Director, Regulatory Operations at Moderna Therapeutics at Moderna. Jonathan Thibault holds Master'S Degree, Clinical Mental Health Counseling from Wake Forest University.
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Email format at fmc-na.com
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{first}.{last}@fmc-na.com
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Profile bio
About Jonathan Thibault
Accomplished leader with over twenty years of technical, quality, and management experience in the biopharmaceutical industry. Results oriented, with proven ability to develop and implement strategic initiatives, build effective teams and provide leadership for cross-functional teams across multiple geographies. Strategic thinker skilled at developing innovative solutions to solve complex problems. Effective communicator capable of providing a vision and implementing a plan to achieve success. Excellent collaborator focused on building strong relationships internally and externally.
Listed skills include Pharmaceutical Industry, Fda, Biotechnology, Clinical Trials, and 16 others.
15 roles
Jonathan Thibault work experience
A career timeline built from the work history available for this profile.
Director, Regulatory Operations At Moderna Therapeutics
Aug 2018 - Jun 2019
Associate Director, Regulatory Operations
- Software:
- Selection, Implementation (DMS, Publishing, Archive Drive, etc), Maintenance, License ManagementVendor Management Liaison:
- Interaction with Publishing Lead, Interaction with Medical WritersPublishing:
- Start to end publishing of Drug Master Files, submission of DMFs via FDA esg.Document Formatting:
- Assistance with formatting requests, template administrator for DMS, eCTD advice for internal team members (specifications/placement)Submission Project Management:
- Manage submission tracking plan, drive document delivery timelines with team members, utilize DMS for document creationArchiving:
Jul 2016 - Aug 2018
Americas Lead - Global Regulatory Operations
- Responsible for vendor management and day to day regulatory operations.
- Responsible for USA, Canada and LatAm Regulatory Affairs Process flows and vendor interactions.
- Responsible for SOP review, creation and editing.
- Major participant in our RIM tool selection committee.
Mar 2015 - Jul 2016
Manager, Global Regulatory Operations
- Completely redesigned Regulatory Information Management System (RIMS) training from Face to Face to an eLearning to free up resources of the trainers and allow new hires to be trained immediately.
- Along with the Global Project Teams (GPT) & the Global Regulatory Affairs (GRA) Representatives, produce the Dossier Compilation Plan (DCP) and achieve GPT sign off on the plan baseline.
- Track and report progress against the DCP to the Regulatory Sub Project Team (RSPT) and the GRA Management Team.
- Raise to the RSPT, GPT and GRA Management Team issues in schedules that may impact review timelines or other risks to quality, time and resources identified by the DCP.
- Ensure that major Submissions are sufficiently resourced within GRO to meet agreed time lines in the DCP and overall project plans. Report issues to GRO Management Team and/or RSPT.
- Decide on dossier Quality Checks to be performed and oversee dispatch of dossiers in liaison with GRA.
Apr 2014 - Mar 2015
Specialist Global Regultory Operations
- RIMS trainer for the Americas and was also the key contact for RIMS users.
- Managed submissions for specific projects by planning compilation and publishing.
- Managed technical projects (Lotus Notes Databases).
- Was responsible for gathering and dissemination of information about electronic eSubmission capabilities from internal and external sources. Acted as the Global Template Standards Administrator.
- Attended Industry conferences and disseminated information to GRO.
- Supported development, implementation and enhancement of application systems (RIMS implementation).Contributed to development and implementation of electronic submission tools (Electronic Common Technical Document eCTD.
Feb 2012 - Apr 2014
Principle Technician Global Regulatory Operations
- Supported the preparation and dispatch of submissions in a timely manner.
- Compiled dossiers (Using electronic submission tools. Hyperlinking and bookmarking of documents used in electronic submissions).
- Performed quality checks and dispatched dossiers.
- Archived published dossiers electronically.Conducted training for departmental members on applications used in GRA.
Feb 2011 - Feb 2012
Senior Clinical Data Manager
May 2009 - Feb 2011
Clinical Data Manager Ii
Jul 2008 - May 2009
Clinical Data Manager Ii
Oct 2006 - Jun 2008
Senior Clinical Data Manager
Harvard Clinical Research Institute
May 2006 - Oct 2006
Clinical Data Manager
Harvard Clinical Research Institute
May 2005 - May 2006
Clinical Data Manager
Research Pharmaceutical Services (Rps)
RPS was a contract research organization. The entire length of my contract was at Serono in Rockland Ma and Geneva Switzerland.
Aug 2001 - May 2005
Clinical Data Manager
Jun 1999 - Aug 2001
Clinical Records Coordinator
Nov 1998 - Jun 1999
3 education records
Jonathan Thibault education
Master'S Degree, Clinical Mental Health Counseling
Wake Forest University
Master Of Arts (Ma), Applied Sociology
Umass Boston
Bachelor Of Arts (Ba), Sociology
University Of Massachusetts Dartmouth
FAQ
Frequently asked questions about Jonathan Thibault
Quick answers generated from the profile data available on this page.
What is Jonathan Thibault's role at their current company?
Jonathan Thibault is listed as Head Regulatory Operations - Pharma at Fresenius Medical Care.
What is Jonathan Thibault's email address?
AeroLeads has found 1 work email signal at @fmc-na.com for Jonathan Thibault.
What is Jonathan Thibault's phone number?
AeroLeads has found 2 phone signal(s) with area code 617 for Jonathan Thibault.
Where is Jonathan Thibault based?
Jonathan Thibault is based in Greater Boston, United States, United States.
What companies has Jonathan Thibault worked for?
Jonathan Thibault has worked for Fresenius Medical Care, Moderna, Ge Healthcare, Emd Serono, Inc., and Johnson & Johnson.
How can I contact Jonathan Thibault?
You can use AeroLeads to view verified contact signals for Jonathan Thibault, including work email, phone, and LinkedIn data when available.
What schools did Jonathan Thibault attend?
Jonathan Thibault holds Master'S Degree, Clinical Mental Health Counseling from Wake Forest University.
What skills is Jonathan Thibault known for?
Jonathan Thibault is listed with skills including Pharmaceutical Industry, Fda, Biotechnology, Clinical Trials, Clinical Development, Sop, Standard Operating Procedure, and U.S. Food And Drug Administration.
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