Project Manager
Resume:
IVY CHUNG
*** * ***** ***., ********, IL *****
EXPEREINCE
ALTAIRE PHARMACEUTICALS INC., RIVER HEAD, LONG ISLAND, NEW YORK 10/10 -present
Project Manager
Initiate electronic submission to FDA
Complied and submitted in 2 months, the company's first ANDA in eCTD format
SAGENT PHARMACEUTICALS INC., Schaumburg, IL 10/07 – 07/09
Regulatory Affairs Manager
Compiled, submitted and obtained the first ANDA approval in 17 months for the Company
§ Reviewed technical documents and formatted them into eCTD for ANDA submission
§ Compiled and submitted 20 ANDAs, all their amendments and FDA questions.
§ Acted as the contact person for FDA in ANDA submissions
§ Composed 4 ANDAs (Docubridge) and sent them to FDA via WebTrader
EBEWE PARENTA PHARMACEUTICALS, Columbia, SC 12/06 – 03/07
Regulatory Affairs Specialist (3 months contract)
§ Presented ADE reporting as post-approval activities
§ Performed QA audits on Stability, Training, Complaints, Deviations and CAPA systems
§ Completed responses to FDA deficiencies: minor amendment to submitted ANDA
§ Performed Canadian CMC submission for an ANDS
AMERICAN PHARMACEUTICAL PARTNERS, Melrose Park, IL 2002 – 03/06
Regulatory Affairs Supervisor
§ Supervised 3 site Scientists at Grand Island, New York and one senior scientist at Melrose Park, IL
§ Submitted over 15 ANDAs for sterile injectables and numerous site changes PAS often with no deficiency from FDA on CMC, nor on sterility assurance section
§ Reformatted submission templates for clarity and efficiency to expedite FDA approvals
§ Compiled and submitted deficiency responses for ANDA amendments and supplements
§ Participated routinely in inter-departmental meetings in submissions and regulatory issues
R.A.CONSULTANT, Toronto, Ontario, Canada 1999 – 2002
Principal Contract Consultant (Self employed)
§ Successfully assisted client in setting up stability program and testing specifications for an inhaler IND submission to Canadian Regulatory Agency
§ Upgraded cGMP in manufacturing of alcohol wipes and other unit dose packages
§ Compiled and submitted annual reports for prescription drug companies
JANSSEN-ORTHO CANADA INC., Toronto, Ontario Canada (client) 8 mos in 1999
Regulatory Affairs Contract Consultant
§ Successfully resolved deficiency questions on 6 IND submissions to TPD (Canada)
§ Implemented all activities related to labeling changes in old and new drugs
§ Teamed QA/QC personnel in labeling compliance and labeling SOP
TARO PHARMACEUTICALS INC., Toronto, Ontario Canada 1997 – 1998
Regulatory Affairs Manager
§ Successfully submitted, passed screening and accepted with no deficiency questions for a nine strengths tablet ANDA for FDA (US) and ANDS for TPD (Canada)
§ Designed, organized and implemented all activities in Canadian Formulary approvals from all provinces
§ Secured from Israel and New York, documentation for product submissions in Canada, the US, New Zealand and the EEC
BIOVAIL CORPORATION INTERNATIONAL, Mississauga, Ontario, Canada 1995 – 1997
Regulatory Affairs Manager
§ Supervised daily activities of 4 associates and 2 secretaries
§ Initiated all activities related to obtaining generic product approvals in USA and in Canada
§ Compiled and submitted the first ANDA including all labeling activities with DDMAC, trained associates in subsequent ANDA, Amendments, Supplements, Annual Report and ADR submissions
§ Obtained FDA approvals for “reduced testing on Coated Beads” and “Coated Beads manufacturing site change” from Puerto Rico, USA to Manitoba, Canada
§ Compiled INDs for clinical studies conducted in the US and Canada
§ Supplied product information for EEC submissions to European countries
§ Designed and co-ordinated RA office move from Scarborough to Mississauga; successfully designed and co-ordinated the construction of a submission workroom
APOTEX INC., Toronto, Ontario Canada 1992 – 1995
US Regulatory Affairs Supervisor
§ Initiated and organized the U.S. Regulatory Affairs department and trained staff
§ Chaired ANDA meetings; co-ordinated exhibit batch manufacturing and testing
§ Assembled, and audited all ANDA related documents, including all labeling activities
§ Compiled and presented Apotex Canada product information to its affiliates (Apotex USA, Torpharm and NuPharm) for development into ANDA products
NOVOPHARM LTD , Toronto, Ontario Canada 1988 – 1992
US Regulatory Affairs Co-coordinator (1990 – 1992)
§ Prepared 20 ANDAs, including all labeling activities with DDMAC, Amendments and Supplements
§ Initiated, monitored and audited bioequivalence studies conducted by bio-houses
§ Audited and collated post-marketing regulatory reports: Annual reports and ADR
Canadian Regulatory Affairs Co-coordinator (1988 – 1990)
§ Formatted and collated submissions for Canadian Agency
§ Prepared more than 25 INDs, ANDS, S/ANDS and S/IND
§ Coordinated with R&D to select scale-up lots for bio-studies or clinical studies
§ Audited test methods and test limits for raw materials and finished products
§ Presented Accelerated Stability data and Shelf-life data in submission format
§ Prepared final dosage form packaging specifications
ALCON CANADA INC., Mississauga, Ontario Canada 1979 – 1985
Regulatory Affairs Co-coordinator (1983 – 1985)
Lab Supervisor (1979 – 1983)
ELI LILLY PHARMACEUTICALS (CANADA) LTD 1973 – 1979
Supervisor Chemistry laboratories (1975 – 1979)
Lab Technician (1973 – 1975)
HENDERSON GENERAL HOSPITAL 1971 – 1973
Biochemistry Technologist
EDUCATION
§ BS, Chemistry, University of Prince Edward Island, 1970
§ Certificate in Management Studies, Sheridan College, 1978
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