David Hallinan
VP, Regulatory Affairs at OBI Pharma, Inc
- Role
- VP, Regulatory Affairs at Obi Pharma
- Location
- Watertown, MA, US
- LinkedIn followers
- 500 followers
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: d••••••••@gmail.com
Experience
VP, Regulatory Affairs
Mar 2014 — Present
Responsible 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).
Education
University College Dublin
BSc
1971 — 1975
Skills
- Ema
- Nda/Maa
- Regulatory Submissions
- Clinical Trials
- Ectd
- Glp
- Biotechnology
- Regulatory Affairs
- Gmp
- Oncology
- Infectious Diseases
- Drug Development
- Sfda
- Gcp
- Pharmaceutical Industry
- Sop
- Fda
- Cta
- Clinical Development
- Pmda
- CRO
- Regulatory Requirements
- Ind
- Clinical Research
- Label Negotiations
- Clinical Hold Discussions
- Quality Assurance
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