Adam Hacker Email and Phone Number
Adam Hacker work email
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Adam Hacker personal email
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Highly effective blue-chip pharmaceutical regulatory affairs leader, operating at Vice President and above level since June 2012. I have extensive experience leading regulatory affairs departments in vaccines, hematology, and oncology therapeutic areas.Currently, I lead in the field of vaccines regulatory affairs and public health, overseeing a substantial portfolio of vaccines in various stages of development and utilizing different technologies.My experience at CEPI has enabled me to develop and engage with a significant network of contacts in regulatory authorities across high, middle, and low-income countries. I continue to have extensive first-hand engagements with regulators, discussing product development strategies and regulatory innovations to accelerate vaccine development in preparation for future outbreaks.My career has been driven by increasingly strategic roles, with expertise spanning a diverse range of departments and therapeutic areas. I have worked with innovative technologies and product classes in both regional and global roles.I excel in driving Quality and Compliance strategies by providing oversight and leadership to manufacturing and R&D organizations.In parallel to my existing role at CEPI, I was appointed as Chair of the Review Panel (MHRA) in January 2024, where I am accountable for statutory and non-statutory reviews of proposals, decisions, and provisional decisions taken by the MHRA.I am also an experienced public speaker, panellist, chair, and moderator at numerous scientific meetings and conferences
European Medicines Agency
View- Website:
- ema.europa.eu
- Employees:
- 1654
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Co-Chair European Platform For Regulatory Science ResearchEuropean Medicines AgencyLondon, Gb -
Chair Of The Mhra Review PanelMedicines And Healthcare Products Regulatory Agency Jan 2024 - PresentLondon, England, GbAccountable for statutory and non-statutory reviews of proposals, decisions and provisional decisions taken by the MHRA -
Head Of Global Regulatory Affairs And QualityCepi (Coalition For Epidemic Preparedness Innovations) Jan 2021 - PresentOslo, NoAccountable for regulatory oversight of all CEPI partner projects providing regulatory oversight to 30 plus vaccine development programmes (COVID and non-COVID portfolio). Oversee the end to end development of awardees' vaccines from a regulatory perspective, including support for regulatory authority meetings and license applicationsCo-Chair of the COVAX Regulatory Advisory Group (co-chair with WHO Head of Regulatory Pre-Qualification) working with fourteen worldwide regulatory authorities and driving alignment and consensus on key COVID related topicsClose one on one working relationship with senior regulators in critical agencies including, US FDA (CBER), MHRA, EMA, Health CanadaResponsible for developing CEPI's regulatory pandemic preparedness plan and driving all vaccine development acceleration initiatives -
Svp Global Head Regulatory Affairs And QualityAutolus Ltd. Aug 2018 - Jan 2021London, GbAutolus Executive Committee member, accountable to Autolus CEO and BoardChair of Autolus' Development CommitteeResponsible for leading and building out the Regulatory Affairs, QA and QC departments in a rapidly growing CAR-T gene therapy biotech company.Leading and validating Autolus' clinical and CMC development strategies with global regulatory authorities.Overseeing the establishment of Autolus' quality management system, moving to a state of inspection readiness, including hosting a successful MHRA GMP inspection.Responsible for selection and implementation of multiple electronic systems including eQMS, Quality System, electronic document management system -
Vp, Head Of Vaccines & Scientific Innovation Projects, Global Regulatory AffairsThe Janssen Pharmaceutical Companies Of Johnson & Johnson Jun 2015 - Jul 2018Raritan, New Jersey, Us -
Ebola Projects Oversight Leader, Vice President, Global Regulatory AffairsThe Janssen Pharmaceutical Companies Of Johnson & Johnson Dec 2014 - Jun 2015Raritan, New Jersey, Us -
Vice President, Emea Therapeutic Area Leader Haematology / Oncology, Emea Medical AffairsThe Janssen Pharmaceutical Companies Of Johnson & Johnson Jun 2012 - Dec 2014Raritan, New Jersey, Us -
Senior Director, Emea Regulatory Therapeutic Area Lead Oncology / HaematologyJohnson And Johnson Jul 2008 - Jun 2012New Brunswick, Nj, UsIn addition I am the Regulatory Representative on EMEA Market Access Leadership Team with responsibilities across the portfolio -
Associate Director, Regulatory AffairsBiogen Idec Sep 2004 - Jun 2008Cambridge, Ma, Us -
Regulatory AdvisorAmersham Health Jun 2002 - Sep 2004
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Regulatory Project ManagerGlaxosmithkline 1998 - Jun 2002Brentford, Middlesex, Gb
Adam Hacker Skills
Adam Hacker Education Details
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National Institute For Medical ResearchMolecular Developmental Biology -
University Of OxfordPure And Applied Biology
Frequently Asked Questions about Adam Hacker
What company does Adam Hacker work for?
Adam Hacker works for European Medicines Agency
What is Adam Hacker's role at the current company?
Adam Hacker's current role is Co-Chair European Platform for Regulatory Science Research.
What is Adam Hacker's email address?
Adam Hacker's email address is ad****@****hoo.com
What schools did Adam Hacker attend?
Adam Hacker attended National Institute For Medical Research, University Of Oxford.
What skills is Adam Hacker known for?
Adam Hacker has skills like Oncology, Regulatory Affairs, Medical Affairs, Therapeutic Areas, Pharmaceutical Industry, Market Access, Hematology, Regulatory Submissions, Strategy, Clinical Development, Drug Development, Pharmacovigilance.
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