Job Description

Ready

to

shape

the

future

of

work

?

At Genpact,

we

don't

just

adapt

to

change

--

we

drive

it

. AI and digital

innovation

are

redefining

industries, and

we're

leading

the

charge

.

Genpact's

AI

Gigafactory

,

our

industry-first

accelerator

,

is

an

example

of

how

we're

scaling

advanced

technology

solutions

to

help

global

enterprises

work

smarter

,

grow

faster

, and

transform

at

scale

. From

large-scale

models

to

agentic

AI,

our

breakthrough

solutions

tackle

companies

'

most

complex

challenges

.

If

you

thrive

in a

fast-moving

,

tech-driven

environment

,

love

solving

real-

world

problems

, and

want

to

be

part

of

a team

that's

shaping

the

future,

this

is

your

moment

.

Genpact (NYSE: G)

is

an

advanced

technology

services and

solutions

company

that

delivers

lasting

value

for

leading

enterprises

globally

.

Through

our

deep

business

knowledge

,

operational

excellence

, and

cutting-edge

solutions

-

we

help

companies

across

industries

get

ahead

and

stay

ahead

.

Powered

by

curiosity

,

courage

, and

innovation

,

our

teams

implement

data,

technology

, and AI

to

create

tomorrow

,

today

.

Get

to

know

us

at genpact.com and

on

LinkedIn, X, YouTube, and Facebook.

Inviting

applications

for

the

role

of

Lead

Consultant

-

Regulatory

affairs

.

We

are

seeking

a

support

for

client

in

their

requested

requirement

for

regulatory

submissions

that

may

have

impact

on

registrations

of

small

molecules

,

biologics

and

combination

products

.

Responsibilities

Support

through

a

number

of

regulatory

functions

specific

to

post-approval

,

lifecycle

management

capacities

which

includes

-

Provide scientific inputs and actively involved in RA CMC strategic discussions

Monitor assumptions, risks and dependencies

Manage and oversee regulatory post approval Chemistry, Manufacturing and Controls (CMC) changes involving deliverables such as:

Provide of regulatory evaluation of change control (affected countries, data/documentation requirements per country, change category per country and regulatory procedure per country) and regulatory strategy

Provide tracking list and review documentation

Dispatch final documentation package to Local Regulatory Affairs (LRA) in affected countries

Monitor timely submission and approval in affected countries

Manage and coordinate responses to health authority questions

Overall planning of all CMC regulatory changes per product together with relevant interfaces

Represent G CMC RA in cross-functional teams

Experience working for major regulated markets - EU (different types of variations, work sharing/ super grouping), US, Japan, China

Manage and oversee support for renewals and post approval CMC commitment involving deliverables such as:

Provide regulatory requirements and regulatory strategy to relevant interfaces

Review documentation

Dispatch final documentation package to Regional Regulatory Lead (RRL) for further distribution to LRAs

Manage and coordinate responses to health authority questions

Overall planning of all renewals per product together with relevant interfaces

Represent G CMC RA in cross-functional teams

CMC

management :

Authoring of Dossier sections - Module 2 and Module 3 - DS and DP

according to the relevant regulatory requirements and GMP rules.

Compilation of CMC documents

for MAA, renewals, variations, commitments, Response to health authority queries

Interaction and cooperation with experts from the relevant departments and CMOs (contract manufacturers and contract laboratories), also in non-European countries, to compile the information and data required for Module 3.2.P.

Interaction with competent authorities in the context of ASMF/DMF and CEP activities.

General

tasks

Support and coordination of audit and inspection related activities

Maintain up-to-date knowledge of regulatory requirements and guidelines

Provide regular progress reports and updates

Acting and living in client processes, and systems

Experience

Relevant experience in CMC tasks and related aspects.

Experience working on biological products required

Qualifications

we

seek

in

you

!

Minimum

Qualifications

Atleast

Bachelor's

degree

required in

for Pharmaceutical:

science

,

engineering

, or related field (advanced degree preferred).

Language

English

Why

join

Genpact?

Be a

transformation

leader -

Work

at

the

cutting

edge

of

AI,

automation

, and digital

innovation

Make

an

impact

- Drive

change

for

global

enterprises

and

solve

business

challenges

that

matter

Accelerate

your

career

-

Get

hands-on

experience

,

mentorship

, and

continuous

learning

opportunities

Work

with

the

best

-

Join

140,000+

bold

thinkers

and

problem-solvers

who

push

boundaries

every

day

Thrive

in a

values-driven

culture -

Our

courage

,

curiosity

, and

incisiveness

-

built

on

a

foundation

of

integrity

and

inclusion

-

allow

your

ideas

to

fuel

progress

Come

join

the

tech

shapers

and

growth

makers

at Genpact and

take

your

career

in

the

only

direction

that

matters

: Up.

Let's

build

tomorrow

together

.

Genpact

is

an

Equal

Opportunity

Employer

and

considers

applicants

for

all

positions

without

regard

to

race

, color,

religion

or

belief

, sex,

age

,

national

origin

,

citizenship

status

, marital

status

,

military

/

veteran

status

,

genetic

information

, sexual

orientation

,

gender

identity

,

physical

or

mental

disability

or

any

other

characteristic

protected

by

applicable

laws

. Genpact

is

committed

to

creating

a

dynamic

work

environment

that

values

respect

and

integrity

,

customer

focus

, and

innovation

.

Furthermore

,

please

do note

that

Genpact

does

not

charge

fees

to

process

job

applications

and

applicants

are

not

required

to

pay

to

participate

in

our

hiring

process

in

any

other

way

.

Examples

of

such

scams

include

purchasing

a 'starter kit,'

paying

to

apply

,

or

purchasing

equipment

or

training.

JobLead Consultant


Primary LocationIndia-Mumbai


ScheduleFull-time


Education LevelBachelor's / Graduation / Equivalent


Job PostingDec 17, 2025, 12:38:08 AM


Unposting DateOngoing


Master Skills ListOperations


Job CategoryFull Time