Associate I– Reg CMC Strategy (LEC Team)

JOB SUMMARY

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.

JOB RESPONSIBILITIES

·

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

RegAtlas

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.

·

Works under the supervision of line manager

·

Ensures

compliance

to

Pfizer

internal

procedures

and

training SOPs.

. Any other requests as assigned by line managers

QUALIFICATIONS / SKILLS

Preferred Education

Minimum

–

Postgraduate

in

Pharmacy

Preferred Experience

0-1 year

in

leading

independently

in

the

Regulatory Sciences

function

in

a reputed

Pharmaceutical

Organization

.

Knowledge

of

NDAs,

ANDAs,

MAAs,

CTDs

and

other regulatory components.

Preferred Attributes

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.

Technical Skills:

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.

Basic

level

of

knowledge

on

general

standards,

processes,

regulatory

guidances

and

policies

of Pfizer/Pharmaceutical manufacturing Industry.

Remain

knowledgeable

about

current

regulations

and

guidance,

interpret

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