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David Hallinan Email & Phone Number
VP, Regulatory Affairs
at
OBI Pharma, Inc
1 work email found
@obipharma.com
1 phone found area 617
LinkedIn matched
✓ Verified Jun 2026
4 data sources
Profile completeness 100%
Current company
Role
VP, Regulatory Affairs
Location
Watertown, Massachusetts, United States
Who is David Hallinan? Overview
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Quick answer
David Hallinan is listed as VP, Regulatory Affairs at OBI Pharma, Inc, based in Watertown, Massachusetts, United States. AeroLeads shows a work email signal at obipharma.com, phone signal with area code 617, and a matched LinkedIn profile for David Hallinan.
David Hallinan previously worked as Vice President, Regulatory Affairs at Idenix Pharmaceuticals, Inc. and Vice President, Regulatory Affairs & QA at Parexel International Corporation. David Hallinan holds Bsc, Ph.D., Biochemistry, Pharmacology from University College Dublin.
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Email format at OBI Pharma, Inc
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{first}.{last}@obipharma.com
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Profile bio
About David Hallinan
International Drug Development & Regulatory Affairs: 25+ years (OBI; Idenix; PAREXEL). Quality Assurance across all GxPs (GMP; GLP; GCP); 25+years (OBI; Idenix; PAREXEL); International trainer on conduct of clinical trials: 7 years (PAREXEL).Since Mar 2014, my focus is in oncology, particularly in the development of immunetherapeutic vaccines against breast, ovarian, lung, colon, gastric and pancreatic cancers. Prior to my current position, my therapeutic experience was in Infectious Disease (Hep C, Hep B, HIV). Prior to that, it was across multiple therapeutic areas including cardiovascular, oncology and CNS.Goal is to continue my strategic and supervisory role in international drug regulatory affairs where my experience, including hands on operational involvement, will enable me to play a key role in efficient global drug development programs while mentoring and guiding regulatory colleagues.Specialities include: Global regulatory development strategies; IND/CTA/NDA/MAA compilation and e-submissions; FDA, EMA and Asian Health Authority meetings; Labeling negotiations; Risk Minimization Plan Development (RMP/REMS); Alliance partnerships; GCP training.Email: dhallinan6@gmail.com
Listed skills include Drug Development, Regulatory Affairs, Clinical Trials, Fda, and 23 others.
Current workplace
David Hallinan's current company
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5 roles · 33 years
David Hallinan work experience
A career timeline built from the work history available for this profile.
Vp, Regulatory Affairs
CurrentResponsible for global regulatory strategy and ongoing Health Authority interactions (FDA; EMA; SFDA; TFDA; PMDA; KFDA) and submissions for each of OBI Pharma's therapeutic cancer vaccine programs in multiple tumor types (breast, lung, gastric, colorectal, ovarian and pancreatic).
Mar 2014 - Present
Vice President, Regulatory Affairs
Idenix Pharmaceuticals, Inc.
Created and managed small but highly efficient Regulatory Affairs & QA groups which oversaw the compilation, submission and approval of 11 IND filings, multiple international CTAs, and 1 approved NDA subsequently resulting in multiple partner MAA approvals WW. Established the necessary e-infrastructure to enable fully compliant e-CTD format submissions..
Sep 2000 - Sep 2013
Vice President, Regulatory Affairs & Qa
Parexel International Corporation
Provided expert regulatory consultation on Sponsor strategic product development issues, including impact of US & international regulations and guidances. Managed the WW GCP QA dept. (N=42) responsible for compliance oversight of all PAREXEL programs as well as other Sponsor specific programs.Coordinated and led IND compilation and submission for HIV.
1993 - Aug 2000
Associate Director Regulatory Affairs
Gh Besselaar/Icp
Provided regulatory and quality assuance oversight of all international clinical trials managed by the Nashville office. Prepared and revied various Sponsor NDA sections. Filed and maintained INDs and DMFs. Conducted on-site QA audits of Sponsors, Investigators and labs, both clinical and analytical. Provided regulatory strategy advice to various Sponsors.
Jun 1988 - Dec 1992
1 education record
David Hallinan education
-
University College Dublin
FAQ
Frequently asked questions about David Hallinan
Quick answers generated from the profile data available on this page.
What company does David Hallinan work for?
David Hallinan works for OBI Pharma, Inc.
What is David Hallinan's role at OBI Pharma, Inc?
David Hallinan is listed as VP, Regulatory Affairs at OBI Pharma, Inc.
What is David Hallinan's email address?
AeroLeads has found 1 work email signal at @obipharma.com for David Hallinan at OBI Pharma, Inc.
What is David Hallinan's phone number?
AeroLeads has found 1 phone signal(s) with area code 617 for David Hallinan at OBI Pharma, Inc.
Where is David Hallinan based?
David Hallinan is based in Watertown, Massachusetts, United States while working with OBI Pharma, Inc.
What companies has David Hallinan worked for?
David Hallinan has worked for Obi Pharma, Inc, Idenix Pharmaceuticals, Inc., Parexel International Corporation, and Gh Besselaar/Icp.
How can I contact David Hallinan?
You can use AeroLeads to view verified contact signals for David Hallinan at OBI Pharma, Inc, including work email, phone, and LinkedIn data when available.
What schools did David Hallinan attend?
David Hallinan holds Bsc, Ph.D., Biochemistry, Pharmacology from University College Dublin.
What skills is David Hallinan known for?
David Hallinan is listed with skills including Drug Development, Regulatory Affairs, Clinical Trials, Fda, Ind, Regulatory Submissions, Gcp, and Pharmaceutical Industry.
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