Ted Hanebach

Ted Hanebach Email and Phone Number

Sr. Director, Regulatory Operations at ICON plc @ ICON plc
leopardstown, dublin, ireland
Ted Hanebach's Location
Dundas, Ontario, Canada, Canada
Ted Hanebach's Contact Details

Ted Hanebach personal email

n/a

Ted Hanebach phone numbers

About Ted Hanebach

Extensive experience in working with electronic regulatory standards. Managed thousends of successful eCTD submission filings. Developed internal processes for eCTD and SPL. Helped to implement eCTD processes for multiple pharmaceutical companies. Developed and delivered numerous XML/eCTD courses for the industry.

Ted Hanebach's Current Company Details
ICON plc

Icon Plc

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Sr. Director, Regulatory Operations at ICON plc
leopardstown, dublin, ireland
Website:
iconplc.com
Employees:
10597
Ted Hanebach Work Experience Details
  • Icon Plc
    Director, Regulatory Operations Icon Plc
    Icon Plc Jan 2018 - Present
    Ontario, Canada
    View
  • Mapi Srs (An Icon Plc Company)
    Director, Regulatory Operations
    Mapi Srs (An Icon Plc Company) Aug 2017 - Present
    Dundas, Ontario
    Extensive experience in working with electronic regulatory standards. Managed thousends of successful eCTD submission filings. Developed internal processes for eCTD and SPL. Helped to implement eCTD processes for multiple pharmaceutical companies. Extensive experience preparing and evaluating the chemistry, manufacturing and control information for INDs, NDAs, NDSs, and MAAs for pharmaceuticals and biologics. Prepared various RA and Document Management trainings. Developed and delivered numerous XML/eCTD courses for the industry.
  • Mapi Group
    Director, Regulatory Operations
    Mapi Group Jan 2015 - Present
    Dundas, Ontario
    View
  • Optuminsight
    Director, Regulatory Operations
    Optuminsight Jan 2011 - Dec 2014
    View
  • I3 Research
    Director, Regulatory Operations
    I3 Research Dec 2009 - Jan 2011
    - Lead i3 Regulatory Operations Unit.- Responsible for i3’s deployment of new technologies and electronic standards.
    View
  • Canreg
    Director, Regulatory Standards
    Canreg Apr 2007 - Dec 2009
    - Lead CanReg’s Regulatory Standards Unit.- Responsible for deployment of new technologies and electronic standards.- Implemented CanReg's eCTD and SPL processes- Participate in EDMS working group.- Design processes for efficient preparation of various electronic submissions. - Participate in the DIA and HL7 working groups.- Participate in System Validation working group.
  • Canreg Inc.
    Associated Director, Cmc And Electronic Submissions; Manager, Cmc; Regulatory Affairs Associate
    Canreg Inc. Apr 1998 - Apr 2007
    - Design and prepare the CMC sections of IND/CTA, NDA/NDS, CTDs to obtain worldwide approval for pharmaceutics and biologics.- Responsible for preparation of submissions in electronic format for FDA (NDAs).- Successfully negotiate regulatory and cGMP issues with FDS, TPD/BGTD and European regulatory agencies.- Create pilots of eCTA, eIND (FDA format) and eCTD in compliance with the ICH specifications.- Develop regulatory (CMC) strategy for candidate drugs in US, Canada, Europe and Asia.- Participate in the DIA, GRASP XML and eCTD groups.- Team leader – development of document management and electronic filing systems.- Team member – MassDocNet group, involved in the development of the XML based software the supports document creation, exchange and management in the Wide Area Network

Ted Hanebach Skills

Regulatory Affairs Ectd Fda Pharmaceutical Industry Regulatory Submissions Regulatory Requirements Validation Ind 21 Cfr Part 11 Pharmaceutics Strategy Computer System Validation Gmp Lifesciences Document Management Regulations Cmc Regulatory Affairs Biotechnology Clinical Trials Gcp Cro Pharmacovigilance Ich Gcp Drug Development Regulatory Operations Life Sciences Clinical Development Cmc Medical Devices Pharmaceuticals Capa Medical Writing U.s. Food And Drug Administration Electronic Common Technical Document Regulatory Strategy Biopharmaceuticals Quality Assurance Sop Glp Chemistry Vaccines Good Clinical Practice Cmc Development Corrective And Preventive Action Cro Management Good Laboratory Practice Standard Operating Procedure

Ted Hanebach Education Details

Frequently Asked Questions about Ted Hanebach

What company does Ted Hanebach work for?

Ted Hanebach works for Icon Plc

What is Ted Hanebach's role at the current company?

Ted Hanebach's current role is Sr. Director, Regulatory Operations at ICON plc.

What is Ted Hanebach's email address?

Ted Hanebach's email address is th****@****oup.com

What is Ted Hanebach's direct phone number?

Ted Hanebach's direct phone number is (859) 223*****

What schools did Ted Hanebach attend?

Ted Hanebach attended Seneca Polytechnic, Seneca Polytechnic, University Of Guelph, Uniwersytet Kardynała Stefana Wyszyńskiego W Warszawie.

What skills is Ted Hanebach known for?

Ted Hanebach has skills like Regulatory Affairs, Ectd, Fda, Pharmaceutical Industry, Regulatory Submissions, Regulatory Requirements, Validation, Ind, 21 Cfr Part 11, Pharmaceutics, Strategy, Computer System Validation.

Who are Ted Hanebach's colleagues?

Ted Hanebach's colleagues are Giovanni Leo, Alina Blajut, Nida Iqbal, Mercedes Rios, Anna Mroz, Ronaldi Rustam, Judy Tay.

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