Catherine Foulon is a skilled professional, working in Voyager Therapeutics, Inc main office of which is in 518. as a Global Reg-Cmc Consultant from 2017. Catherine Foulon gained professional experience in more than 15 positions at various companies. Catherine Foulon went to the Université De Tours and was studying from 1989 to 1991. Waltham, Massachusetts is the area, where this professional was lastly known to be settled. Their phone number and email can be accessed through this website on demand.
Name variants:
Cathryn Foulon,
Catheryn Foulon,
Catharine Foulon,
Cathleen Foulon,
Cat Foulon,
Cattie Foulon,
Catty Foulon,
Cathie Foulon,
Cathy Foulon,
Cassie Foulon,
Kit Foulon,
Kitty Foulon,
Kittie Foulon,
Caty Foulon,
Kate Foulon
Last updated Jul 03, 2024
Contact Information
Last Update
Jun 30, 2022
Email
ca**@yahoo.com, ca**@baxter.com, ca**@amedrapharma.com
Location
Waltham, MA
Company
Workplace
Global Reg-Cmc Consultant
Cambridge, MA
Industry
Biotechnology, Commercial Physical Research
Colleagues
Work History
Global Reg-Cmc Consultant
75 Sidney St, Cambridge, MA 02139
General Reg-CMC support for the various upcoming submissions
from Nov 2017
Cmc Project Manager
1000 Winter St, Waltham, MA 02451
CMC Project Management, including cost-planning for the Immuno-oncology Franchise until full-time employee was hired.
Mar 2017 — Sep 2017
Regulatory Affairs Consultant
333 Twin Dolphin Dr SUITE 600, Redwood City, CA 94065
Author the Module 3 Sections for a biosimilar Application - Project-managed the full Application with regular metrics reports to Upper Management
Jul 2016 — Apr 2017
Consultant, Global Regulatory Cmc
Illinois
Shire acquired Baxalta on June 3, 2016. Following this date, this page will no longer be actively monitored. There will be no updates or responses posted on this page. For continued news and...
Aug 2014 — Mar 2017
Consultant, Regulatory Submission
Manage timelines and deliverables for the regulatory submissions to the Flu and Meningitis Franchises.
Feb 2014 — Jul 2015
Consultant, Regulatory Cmc
2 Walnut Grove Dr SUITE 190, Horsham, PA 19044
Support the CMC activities from NDA to variations and Annual Reports.
Jan 2014 — May 2015
Consultant, Global Regulatory Cmc
1 Waukegan Rd, North Chicago, IL 60064
Support global CMC regulatory filing such as drafting/reviewing of Module 2 and Module 3. Manage the global CMC filing strategy by establishing timelines and tracking progress. Readily edit ...
Jun 2013 — Aug 2014
Consultant, Global Regulatory Cmc
40 Landsdowne St, Cambridge, MA 02139
Support CMC regulatory activities such as drafting/reviewing global CTAs and MAAs. Implement cross-departmental business tools e.g. Health Agency query databases; global dossier tracker. Lea...
Jul 2013 — Feb 2014
Consultant, Regulatory Cmc
Compile Development History of a biologic (Hemophillia) in preparation of the BLA filing
May 2012 — Nov 2012
Project Manager, Global Regulatory Cmc
2000 Galloping Hill Rd, Kenilworth, NJ 07033
Manage the gathering of global regulatory requirements for post-approval products across the world. From data collection, review and data management.
Apr 2011 — Nov 2012
President and Lead Reg-Cmc Consultant
146 Bishops Forest Dr, Waltham, MA 02452
Provide CMC regulatory consulting services to the Pharma/Biotech industry. Manage acute and complex projects. Author BLA/NDA, post-approval variations and briefing books. Project manager for...
from Jan 2011
Director, Regulatory Affairs
50 Northern Ave, Boston, MA 02210
Manage the CMC sections for the company's first NDAs. Extended to the tracking of the full NDA/NDS.
Jan 2009 — Dec 2010
Director, Radiopharmaceutical Development
Managed the development effort for a radiotherapeutic for prostate cancer; Managed CMOs involved in the manufacturing/testing of the Company's radiopharm portfolio (biologics and small molec...
Jan 2007 — Dec 2008
Lead, Timeline and Resource Management
New Jersey
Managed the pre-clinical timeline and resource activities for the full portfolio (Discovery and Development products)
Jun 2005 — Dec 2006
Project Manager
Managed CMC activities for a clinical study (lung cancer, radiotherapy)
2002 — 2005
Education
1989 — 1991
Occupations
Executive
Chairperson
Counselor
Project Manager
Chief Executive
Advisor
Project Managers
Skills
Regulatory Submissions
Regulatory Affairs
Clinical Development
Pharmaceutical Industry
Biotechnology
Fda
Technology Transfer
Drug Development
Gmp
21 Cfr Part 11
Clinical Trials
Cmc
Regulatory Requirements
U.s. Food and Drug Administration
Validation
Ind
Change Control
Glp
Biopharmaceuticals
Sop
Pharmaceutics
Gxp
Vaccines
Cro
V&V
Standard Operating Procedure
Good Laboratory Practice
Good Clinical Practice
Ectd
Computer System Validation
Nuclear Medicine
Capa
Gcp
Corrective and Preventive Action
Cro Management
Electronic Common Technical Document
Verification and Validation
Lims