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Marketing
Applications
(NDAs/MAAs/NDSs)
1. Successful FDA
filing/approval of the
NDA for Edluar
(sublingual Ambien).
Led and managed all
project
activities/managed a
team of 26+
professionals
including data
management/eCTD, etc.
(Sept., 2008 to March,
2009)
2. Successful
completion of CMC
activities leading to
FDA filing of NDA for
an oncology/orphan
drug product
(sterile/semi-synthetic).
Led all
technical/regulatory
activities including
oversight of several
CMOs and provided
strategic direction
and implementation of
improved GMP
compliance (May, 2009)
3. Successful
completion of CMC
activities leading to
FDA filing of NDA for
an oncology/opiod pain
management product.
Led all
technical/regulatory
activities including
oversight of several
CMOs with complicated
contractural
obligations and other
service providers
(July, 2009)
4. Successful
completion and filing
of the NDA for a
CNS/MDD extended
release product. Led
all regulatory
activities including
managing project
activities with
numerous CRO/CMOs and
other service
providers (May, 2007)
5. Led regulatory
activities leading to
successful filing and
approval of an
in-licensed injectable
anti-fungal drug. This
contributed
significantly to the
financial value of the
company resulting in
its acquisition for
about 2 billion US
dollars (2002-2007)
6. Approval of NDA for
oncology compounds.
Made significant
contributions to the
chemistry,
manufacturing and
controls aspects of
the NDA leading to its
approval in global
markets (2003)
7. Approval of NDA for
a pain management
drug. Made significant
contributions to the
chemistry,
manufacturing/controls
and regulatory aspects
of the NDA leading to
its US approval
(2005/2006)
8. Approval of
NDA/MAA/NDS for a
cholesterol-lowering
drug. Led the
chemistry,
manufacturing/controls
and regulatory aspects
of the NDA leading to
its approval in the
US/EU/Canada
(2005/2006)
9. Global Regulatory
Agency Inspections –
Led inspection
activities for
approval of over 24
clinical/manufacturing
and laboratories
(GLP/GCP & GMP) to
support product
approvals in global
markets (2002-2008)
Global
Strategic
Regulatory
Meetings,
Negotiations/Development
Submissions
•
Led the successful
completion of 41+
major strategic
FDA/Canadian/EMEA
meetings for over 31
products in all
phases of
development covering
8 therapeutic areas
(March, 2002 – 2013)
•
Obtained IND
Exemption for an
oncology
device/combination
product for a
University/Ethics
Committee
(2005/2006)
•
Obtained FDA
approval for
designation of a
drug/device
combination product
to be led by CDRH
(2005)
•
Received excellent
recognition from FDA
(CDER - Division of
Neurologic/Psychiatric
products) for
strategic agency
meeting preparation
•
Averted/or resolved
various issues
related to clinical
hold for numerous
products in clinical
trials
•
Successful
preparation of over
98 submissions
(IND/CTA/IDE, etc.)
for timely
initiation of
clinical/preclinical
studies in 30+
countries
•
Successful
preparation of over
47 DMF/CEP
submissions for
numerous active
ingredients
(human/veterinary
use) in 28+
countries
Post-Approval
Product
Recalls/Life-Cycle/Supply
Chain Management
•
Led and averted
recall by the
Canadian Agency
(TPD) of a major
NSAID. This included
identifying all
deficiencies and
oversight of various
PK/PD, manufacturing
and regulatory
activities
(2007/2008)
•
Pro-actively led
strategic efforts
for preventing
facility/CRO
compliance issues
and supported
maintenance of
products in global
markets (2002-2008)
Major
Professional Drug
Development
Training
•
US National
Institute Health
(NIH, Divisions of
Allergy/Immunology
& Infectious
Diseases) – Training
in the Requirements,
Processes &
Implementation of
the EU Clinical
Trials Directive
(2005/2006)
•
Endo
Pharmaceuticals,
Inc. – Training in
development of
Prescription drugs
(2005/2006)
•
Elan
Pharmaceuticals,
Inc. – Training in
Drug Development
& Quality
Systems (2005/2006)
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