Pfizer
India - Chennai
+ 1 other location
Functions as a Strategist for Brands-LEC team, working with Global Regulatory Strategist (GRS-CMC) and Cross
Functional
Teams
to
prepare
and
submit
the
variations
for
entity
name
change
across
global
markets including US, EU & ROW as per defined timelines.
·
Manages
day-to-day
regulatory
activities
associated
with
assigned
LEC
variations
within
agreed upon timelines.
·
Evaluate change controls for completeness, accuracy and
required
supporting documents.
Initiate change controls when needed.
·
Performs
Market
Impact
Assessment
(MIA)
for
the
specific
entity
name
change.
·
Runs
the
Reg Atlas
to
determine
the
filing
action
and
impacted
sections specific for entity name change and to obtain confirmation from the Regional Regulatory Lead.
·
Search
Regulatory
databases
for
Common
Technical
Document
components
or
request them
from appropriate market contacts, when not available.
·
Familiarity
with
global
guidelines
for
filing
Legal
Entity
Changes
(LEC)
and
run
corresponding
reports in the regulatory requirements database.
·
Should
be familiar
with
submission
grouping
practices.
·
Interpret
and
apply
global/regional
CMC
regulatory
policies.
·
Request
documents
from
the
sites/markets/center
functions
as
needed.
·
Request
Ancillary
documents
from
Ancillary
documents
team.
·
Communicate
with
markets
if
clarification/prioritization
is
needed.
·
Follow
up
with
all
responsible
disciplines
to
be
able
to
meet
timelines.
·
Authoring
of
the
impacted
CMC
sections
i.e.
Module
3
under
the
guidance
from
the
product strategists
as appropriate and within agreed timelines.
·
Responsible
for
obtaining
approval
in
Reg-459
form
from
GRS CMCs
on
the
completion
of
authoring the sections.
·
Utilizes
Pfizer’s CMC
systems, i.e.
GDMS,
PDM,
SPA, PEARL, RegAtlas, Rosetta etc.,
as appropriate.
·
Must
be
extremely
organized
as
LEC projects
can
run
across
multiple
products/markets.
·
Ensures
compliance
to
Pfizer
internal
procedures
and
training
SOPs
.
·
Ownership of process improvements, metrics and delivery risks
·
Team player and work under matrix environment
·
Works under the supervision of line manager
.
Escalation management and cross-functional issue resolution.
·
Accountability for defined team milestones, rather than only assigned individual activities.
·
Technical coaching or knowledge sharing within the work team.
·
Takes
responsibility
for
a
portion
of
the
work
team’s
milestones/ deliverables.
.
Any other requests as assigned by line managers.
QUALIFICATIONS / SKILLS
Minimum
–
Postgraduate in
Pharmacy
Minimum 7
Years
in
leading
independently
in
the
Regulatory Sciences
function
in
a reputed
Pharmaceutical
Organization
.
Knowledge
of
NDAs,
ANDAs,
MAAs,
CTDs
and
other regulatory components.
Excellent
oral
and
written
English
communication
skills.
Good
conceptual,
analytical,
problem
solving, reasoning and organizational skills. Should be change agile, prioritization of projects with minimum guidance. Attention to detail and accuracy required.
Regulatory requirements
of
post
approval
changes
for
US,
EU
and
ROW
markets.
Oral
Solid
Dosage
form
and
sterile
injectable
manufacturing
and
regulatory
data
requirements
for post approval submissions.
Knowledge
in
retrieving
information
from
company’s
and
regulatory agency
databases.
Advanced level
of
knowledge
on
general
standards,
processes,
regulatory
guidances
and
policies
of Pfizer/Pharmaceutical manufacturing Industry.
Remain
knowledgeable
about
current
regulations
and
guidance,
interprets
and
notifies appropriate personnel.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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Regulatory Affairs