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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
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Vp, Regulatory AffairsObi Pharma, IncWatertown, Ma, Us
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Vp, Regulatory AffairsObi Pharma, Inc Mar 2014 - PresentTaipei City, Taiwan, TwResponsible 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). -
Vice President, Regulatory AffairsIdenix Pharmaceuticals, Inc. Sep 2000 - Sep 2013Created 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. Developed regulatory strategy for the global development of lead investigational HBV and HCV programs. Led the development teams at key FDA, EMA, EU National, China SFDA, Japan PMDA and Taiwan CDE meetings. Oversaw QA across all GMP, GLP & GCP operations.
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Vice President, Regulatory Affairs & QaParexel International Corporation 1993 - Aug 2000Provided 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, cardiovascular and hematological indications. Acted as key trainer for international GCP training seminars with FDA and a variety of Sponsors. Represented multiple Sponsors at key FDA pre-IND and EOP2 meetings.
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Associate Director Regulatory AffairsGh Besselaar/Icp Jun 1988 - Dec 1992Provided 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 and liaised with Sponsor regulatory groups in implementation of agreed strategy. Attended key Sponsor FDA drug development meetings.
David Hallinan Skills
David Hallinan Education Details
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University College DublinPharmacology
Frequently Asked Questions about David Hallinan
What company does David Hallinan work for?
David Hallinan works for Obi Pharma, Inc
What is David Hallinan's role at the current company?
David Hallinan's current role is VP, Regulatory Affairs.
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David Hallinan's email address is dh****@****ail.com
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What schools did David Hallinan attend?
David Hallinan attended University College Dublin.
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What skills is David Hallinan known for?
David Hallinan has skills like Drug Development, Regulatory Affairs, Clinical Trials, Fda, Ind, Regulatory Submissions, Gcp, Pharmaceutical Industry, Clinical Development, Oncology, Biotechnology, Clinical Research.
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