Anna Hertzberg Email and Phone Number
Anna Hertzberg work email
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Anna Hertzberg personal email
Anna has more than eight years of experience in regulatory strategy and regulatory project management. As a consultant, she has contributed to cross functional teams in successful health authority meetings and initial and subsequent IND submissions, navigating difficult outcomes in the areas of oncology, neurology, gene therapy and vaccines. Anna provides regulatory support for product development programs ranging from early-to late-stage development. Prior to joining Halloran, Anna was a Manager of Global Regulatory Affairs Development at Takeda Pharmaceutical Company. In this role, she served as the regulatory lead for an approved lymphoma product and led a team of regulatory professionals. Additionally, Anna provided strategic input to ensure successful execution of the regulatory strategy including FDA and EMA meetings and spearheaded responses to global health authority queries during review of clinical trial applications and marketing authorizations. Further, Anna was instrumental in the maintenance of orphan drug designations, INDs and NDAs for various molecules and indications, including negotiating FDA agreement on the design of Phase 3 and pediatric trials. Anna began her career as a neuroscientist in labs at Wellesley College and MIT assisting in mouse research on memory and hormones.
Boston Biodevelopment Llc
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Senior ConsultantBoston Biodevelopment Llc Jul 2024 - PresentBoston, Massachusetts, Us
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Regulatory Affairs ConsultantHalloran Consulting Group, Inc. Jun 2021 - Feb 2024Boston, Massachusetts, UsI contribute to cross functional teams in successful health authority meetings and initial and subsequent IND submissions, navigating difficult outcomes in the areas of oncology, neurology, gene therapy and vaccines. I provide regulatory support for product development programs ranging from early-to late-stage development. -
Global Regulatory Affairs, ManagerTakeda Oncology Oct 2018 - Jun 2021Cambridge, Ma, UsLead Global Regulatory Team on a complex oncology program including maintaining 6 indications and approvals in over 75 countries.Attend as well as assist in planning and implementing FDA interactions to progress regulatory strategy for cancer therapy into pediatrics and earlier lines of therapy.Represent regulatory affairs on teams conducting Phase 3 trial, applications for supplements and other labeling updates and responses to queries.Plan and facilitate various submissions to FDA (IND and NDA), Health Canada and other health authorities including authoring and reviewing various documents. -
Global Regulatory Affairs Development Senior AssociateTakeda Oncology May 2015 - Oct 2018Cambridge, Ma, UsRepresent regulatory affairs on teams to plan Phase 3 trials, applications for new indications and other labeling updates and responses to queries.Assist in submissions for marketing applications and subsequent activities for the company's newest cancer therapy, which was approved by FDA in November 2015 and EMA in November 2016. Plan and facilitate submissions to FDA (IND and NDA), Health Canada and other health authorities including authoring and reviewing various documents. As an intern Summer of 2015 constructed a database of current and past clinical trials for various oncology indications.
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Assistant ManagerPlato'S Closet Oct 2014 - May 2015Train new employeesSort and price clothes from customersCommunicate the needs of the store to co workers and the ownerHelp create outfits for display and customers
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Mad ScientistMad Science Group Aug 2013 - Aug 2014Montreal, Quebec, CaRan science shows at birthday parties and other events.Teach an hour long class 5x a week to elementary school kids. -
Research Technician/ Lab ManagerWellesley College Sep 2012 - Mar 2013Wellesley, Ma, UsTake notes and implement changes according to weekly meetings of lab.Taught and performed mouse handling techniques, injections, perfusions and sectioning of tissue. Maintained laboratory inventory, ordered reagents and shipped out DNA as well as general management of lab. -
Research TechnicianMit Aug 2011 - Jul 2012Cambridge, Ma, UsHelped improve Morris water maze set up: revised protocol, recorded results and analyzed findings.Developed expertise in various sites of intracranial injections using stereo tax, perfusion, brain extraction and sectioning with vibratome and cryostat. -
OperatorOberlin College Living Machine Mar 2007 - Aug 2011Completed weekly test of fecal coliform using filters and incubationTested and calibrated pH and DO probesMaintained grey water systemLed tours of machine, building, and facilities
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Unit DirectorCamp Namanu Jun 2009 - Aug 2010During two summers I supervised up to six counselors and 26 campers Gave feedback and written weekly evaluations to staffPlanned and coordinated unit activities and cabin schedules
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Conservation Field InstructorMesd Outdoor School Apr 2009 - Jun 2009Developed recycling and conservation programsCompiled a curriculum on various methods of compostingSupported fellow staff in daily activities
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CounselorCamp Namanu Jun 2007 - Aug 2007Led campers in activities including: ropes course, duck pond, swimming, and gamesCounseled children from seven through 15
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Research InternOregon Health And Sciences University Jun 2005 - Aug 2005Portland, Oregon, UsConducted independent research testing how deletion of the Srd5a1 gene affects alcohol-related behaviors of miceCompleted five behavioral tests on an sample of 80 micePrepared and presented PowerPoint and poster on research results -
Research InternOhsu Jun 2004 - Aug 2004Portland, Oregon, UsSectioned and mounted mice brains on slidesConducted gel electrophoresis and DNA isolationWeaned, weighed and maintained colony of mice
Anna Hertzberg Skills
Anna Hertzberg Education Details
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Regis CollegeRegulatory And Clinical Research Management -
Boston CollegeClinical Research
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Oberlin CollegeNeuroscience
Frequently Asked Questions about Anna Hertzberg
What company does Anna Hertzberg work for?
Anna Hertzberg works for Boston Biodevelopment Llc
What is Anna Hertzberg's role at the current company?
Anna Hertzberg's current role is Regulatory Affairs Consultant for Top Performing Drug Development Teams.
What is Anna Hertzberg's email address?
Anna Hertzberg's email address is an****@****eda.com
What schools did Anna Hertzberg attend?
Anna Hertzberg attended Regis College, Boston College, Oberlin College.
What are some of Anna Hertzberg's interests?
Anna Hertzberg has interest in Children, Education, Science And Technology, Medical Devices For Neuromodulation, Learning And Memory Research, Human Rights, Health.
What skills is Anna Hertzberg known for?
Anna Hertzberg has skills like Research, Pcr, Western Blotting, Neuroscience, Immunohistochemistry, Science, Laboratory, Data Analysis, Spss, Fluorescence Microscopy, Statistics, Molecular Biology.
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