Vice President Regulatory Affairs Cmc And Executive Lead
Syner-G Biopharma Group
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Judy Hauser Email & Phone Number
Vice President Regulatory Affairs CMC and Executive Lead
at
Syner-G BioPharma Group
1 work email found
@valeant.com
1 phone found area 800
LinkedIn matched
✓ Verified July 2026
4 data sources
Profile completeness 100%
Current company
Role
Vice President Regulatory Affairs CMC and Executive Lead
Location
Long Beach, New York, United States
Company size
Who is Judy Hauser? Overview
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Quick answer
Judy Hauser is listed as Vice President Regulatory Affairs CMC and Executive Lead at Syner-G BioPharma Group, a with 314 employees, based in Long Beach, New York, United States. AeroLeads shows a work email signal at valeant.com, phone signal with area code 800, and a matched LinkedIn profile for Judy Hauser.
Judy Hauser previously worked as Regulatory Affairs Consultant at St. Jude Regulatory Consulting Llc and Executive Director Regulatory Affairs at Bausch Health Companies Inc.. Judy Hauser holds Bachelor'S, Chemistry/Biochemistry from Queens College.
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{first}.{last}@valeant.com
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Profile bio
About Judy Hauser
Certified Global Regulatory Affairs professional with expertise in developing and executing global regulatory strategies for drug, medical device and nutritional products. Strengths include preparing global regulatory submissions including Briefing Documents, INDs, CTAs, ITAs, IDEs, NDAs, ANDAs, MAAs, PMAs, 510(k)s, CE Mark Technical dossiers and Annual Reports. Lead all communications with Health Authorities and ensure quality compliance. A results-driven leader adept at managing change while working in a fast-paced, dynamic work environment with a standard of excellence.
Listed skills include Regulatory Affairs, Regulatory Submissions, Fda, Pharmaceutical Industry, and 21 others.
Current workplace
Judy Hauser's current company
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Syner-G Biopharma Group
12 roles · 31 years
Judy Hauser work experience
A career timeline built from the work history available for this profile.
Role listed
Vice President Regulatory Affairs Cmc And Executive Lead
Syner-G Biopharma Group
Regulatory Affairs Consultant
St. Jude Regulatory Consulting Llc
Dec 2019 - Sep 2020
Executive Director Regulatory Affairs
Sep 2017 - Aug 2019
Sr. Director Regulatory Affairs, Surgical Division
Oversee Regulatory Affairs for the Surgical Division. Responsible for global regulatory strategies, global regulatory submissions and Technical File dossiers. Manage the Surgical Regulatory Affairs team.
Dec 2015 - Aug 2017
Head, Global Regulatory Affairs, New Growth Opportunities & Research Franchise
Prepare/implement global regulatory strategies for drug, medical device and nutritional product development programs. GRA Lead on all project teams, Regulatory sub-teams and for communications with Health Authorities. Prepare global regulatory submissions including Briefing Documents, INDs, CTAs, IDEs, NDAs, 510(k)s and CE Mark Technical dossiers.
2013 - Sep 2015
Director Global Regulatory Affairs, Pharmaceuticals-Otcs & Nutritionals
Prepared/executed global regulatory strategies for all OTC drug, medical devices and nutritional products development programs., life-cycle management activities, including geographical expansion. GRA Lead on all project teams, Regulatory sub-teams and communications with Health Authorities. Compiled global regulatory submissions including Briefing Documents, INDs, NDAs, MAAs, and CE Mark Technical dossiers.
2009 - 2013
~4 yrs
Director Regulatory Affairs
Time-Cap Labs, Inc.
Wrote and submitted all ANDA submissions and Annual Reports, as well as EU MAAs. Managed all regulatory and quality compliance activities including internal and external auditing programs. Oversaw all labeling activities. Developed/implemented global regulatory strategies for all OTC, generic drug and nutritional product development and life-cycle management activities, including CMC, and change controls. Primary interface with FDA for all submission and inspection activities.
2007 - 2009
~2 yrs
Sr. Regulatory Affairs Associate
Wrote, compiled and submitted ANDAs and Annual Reports to FDA. Regulatory Lead for project teams and primary interface with FDA for all projects. Completed regulatory assessment for change controls.
2006 - 2007
~1 yr
Sr. Ra Associate
Wrote and submitted Briefing Documents, IDEs, 510(k)s, PMAs and Annual Reports for US, compiled and maintained CE Mark Technical dossiers for EU for new development programs as well as life-cycle management activities. Prepared regulatory assessment for and approved Engineering Change Notices. Oversaw all labeling review and approval.
2004 - 2006
~2 yrs
Sr. Manager Regulatory Affairs
E-Z-Em, Inc.
Compiled and submitted 510(k) submissions, compiled/maintained CE Mark Technical dossiers for electromechanical, software-driven and other medical devices. GRA lead and primary interface with FDA and Notified Bodies/Competent Authorities. Completed regulatory assessment and approved Engineering Change Notices. Reviewed and approved all labeling materials.
1996 - 2004
~8 yrs
1 education record
Judy Hauser education
-
Queens College
FAQ
Frequently asked questions about Judy Hauser
Quick answers generated from the profile data available on this page.
What company does Judy Hauser work for?
Judy Hauser works for Syner-G BioPharma Group.
What is Judy Hauser's role at Syner-G BioPharma Group?
Judy Hauser is listed as Vice President Regulatory Affairs CMC and Executive Lead at Syner-G BioPharma Group.
What is Judy Hauser's email address?
AeroLeads has found 1 work email signal at @valeant.com for Judy Hauser at Syner-G BioPharma Group.
What is Judy Hauser's phone number?
AeroLeads has found 1 phone signal(s) with area code 800 for Judy Hauser at Syner-G BioPharma Group.
Where is Judy Hauser based?
Judy Hauser is based in Long Beach, New York, United States while working with Syner-G BioPharma Group.
What companies has Judy Hauser worked for?
Judy Hauser has worked for Syner-G Biopharma Group, St. Jude Regulatory Consulting Llc, Bausch Health Companies Inc., Novartis Consumer Health, and Bausch & Lomb.
How can I contact Judy Hauser?
You can use AeroLeads to view verified contact signals for Judy Hauser at Syner-G BioPharma Group, including work email, phone, and LinkedIn data when available.
What schools did Judy Hauser attend?
Judy Hauser holds Bachelor'S, Chemistry/Biochemistry from Queens College.
What skills is Judy Hauser known for?
Judy Hauser is listed with skills including Regulatory Affairs, Regulatory Submissions, Fda, Pharmaceutical Industry, Chemistry, Gmp, Clinical Development, and Leadership.
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