Senior Technical Regulatory Advisor – Pharmaceuticals (Senior/Executive Direct

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that

the information I provide in my application will be processed in line with

Takeda’s

Privacy Notice

and

Terms of Use .

I further attest that all information I submit in my employment application

is

true to the best of my knowledge.Job Description

Sen

ior Technical Regulatory Advisor –

Pharmaceuticals

(Senior/E

x

ecutive Director)OBJECTIVES/ PURPOSETo define and implement an

external engagement strategy,

governance

and associated

capabilities

in line with the patient centric values of Takeda

to ensure that Takeda

is recognized by regulatory authorities and industry peers as a thought leader in the areas of

innovation,

sc

i

ence/technology,

Regulatory

sciencesEngaging a network of company Subject Matter Experts across

Global

R&D (Pharmaceutical Sciences, CMC Regul

a

tory Affairs & Devices), Global

Manufacturing

Supply

and

Global

Quality

to

monitor

and influence the evolving

technical regulatory /quality CMC

environment and execute internal change to continuously improve our products,

systems

and

submissionsCollaborating with Regulatory policy and Intelligence team as well as the global quality policy

intelligence

team to develop

internal processes and communication mechanisms to assess emerging regulatory expectations for their impact on the company, and to achieve the overall vision and

obje

ctivesEngage

with

GRA CMC & Device

Leadership in the talent

development

processes

to

provide

mentoring of

Top Talent and

Subject

Matter

Experts

to

enhance

external

technical advocacy/

influencing

capability

.A

CCOUNTABILITIESAccountable for mentoring and coaching team members to enable proactive and

timely

communication of regulatory risks, challenges, and opportunities to management to help address them in a systematic and thoughtful manner.Collaborate

closely

with

Technical

SME’s

across

Takeda

to

craft

company positions to

influence

HA’s

and

thereby

enable

Technical

innovation

and

incorporation

of

digital

innovation

into

Takeda

development

and commercial framework.

Engage

with

regulators

and

industry

associations

to

represent

the

c

ompany on

strategic

topics

.Builds and

manages

relationships

through

active

partnering

with key

internal

(GRA, GRA CMC,

Pharm

SCi

GMS, GQ etc.) and

external

stakeholders (Industry

representatives

, PHRMA, Health

authorities

etc

).

Relationship

management and

constructive

partnering

with Health

Authorities

and

relevant

local

organizations

to drive

Takeda

positions and

influence

scientific

approach

and

though

t

process

to

technical topics

.Ensure

that

a network of

subject

matter

experts

exists

and

mentors

/

supports the

internal

key opinion leaders in

their

external

engagement activities.Ensure

early

identification

and

assessment

of

emerging

technical RA

topics

/

expectations

,

prioritize

and gain senior leader

alignment

to

define

the

company´s

strategy and

involvement

.Influences

changing

regulations

and

guidance

;

interfaces

with

outside

regulatory

agencies

and trade

associations

and acts

as

an advisor/liaison to senior management to plan,

evaluate

and

recommend

CMC Module 3/Module 2

submissions

with

intent

to

streamline

and

increase

efficiency

through

use of

automation

and

digital

tools.Contribute to creating and communicating an employment culture and values which attract,

retain

, and develop the most effective people.This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

:Bachelor’s

or

Advanced Degree in Life Sciences,

Pharmacy

,

Chemistry

,

Biology

or

related

discipline.Languages :

Fluent

in English (

oral

and

written

);

additional

languages

desirableMinimum of

15-

20

years

of

experience

within

regulatory

agencies

or the

Pharmaceutical

Industry

including

significant

leadership

experi

ence

in Quality

/

Regulator

y

/Technical

area

.

A candidate with strong experience in

small molecules

is highly preferred.The candidate must

demonstrate

the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this

roleSignificant

understanding

and track record in

dealing

with international

regulations

and policies setting

processes

of major

regulatory

agencies

(e.g. US FDA, EU, PMDA, WHO).Actively

engaged

in major

industry

associations

(e.g. EFPIA,

PhRMA

, PDA, ISPE, DIA) and joint

regulator

/

industry

initiatives

(e.g. ICH).Strong

communication

,

collaboration

,

negotiation

,

problem

solving and

interpersonal

skills. Has a

proven

track record of working

across

regulator

/

industry

boundaries

to

find

common

solutions

and drive positive impact and benefits for

patients

.Must have proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented

clearly

and conclusions are adequately supported by dataHigh

organization

awareness

(e.g.

interrelationship

of

departments

, business

priorities

),

including

significant

experience

working cross-

functionally

and in

teams

.Takeda Compensation and Benefits SummaryWe understand compensation is

an important factor

as you consider the next step in your career. We are committed to

equitable

pay for all employees, and we strive to be more transparent with our pay practices.For Location:Boston, MA

U.S. Base Salary Range:205,100.00 - 322,300.00

The estimated salary range reflects

an anticipated

range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education

attained

, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

The actual base salary offered will be

in accordance with

state or local minimum wage requirements for the job location.U.S. based

e

mployee

s

may be eligible for

s

hort

-

t

erm and/

or

l

ong-

t

erm

incentive

s

.

U.S.

based employees

may be

eligible to

participate

in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and

well-being

benefits, among others. U.S.

based employees are also eligible to receive, per calendar year, up to

80 hours

of sick time, and new hires are eligible to

accrue

up to

120 hours of paid vacation.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ExemptYes#J-18808-Ljbffr