Manager or Senior Manager, Growth & Emerging Markets - GI/NS, Global Regulatory Affairs
Company: Takeda Pharmaceutical
Location: North Bergen
Posted on: May 9, 2022
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 and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAre you looking for a patient-focused
company that will inspire you and support your career? If so, be
empowered to take charge of your future at Takeda. - Join us as a
Manager or Senior Manager, Growth & Emerging Markets - GI/NS,
Global Regulatory Affairs in our Cambridge office.Here, everyone
matters and you will be a vital contributor to our inspiring, bold
mission. As a Manager or a Senior Manager, Growth & Emerging
Markets - GI/NS, Global Regulatory Affairs working on the Research
and Development team, you will be collaborate to define, develop
and lead Emerging Markets strategies to maximize regulatory success
towards achievement of program objectives. A typical will
include:POSITION OBJECTIVES:Defines, develops and leads Emerging
Markets strategies to maximize regulatory success to strengthen the
product development plan and to enable patient access in alignment
with program objectives, including all aspects of submission and
timely approval of investigational applications, market application
and life-cycle management as well as. Directly manage staff
members, provide direction, support, mentoring, and strategic
guidance to support scope of project work, when applicable. - - - -
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -POSITION
- Collaborates to define, develop and lead Emerging Markets
strategies to maximize regulatory success towards achievement of
- Manages, plans and executes the preparation, submission and
timely approval of investigational applications, market
applications, variations, post approval reporting obligations and
general product life cycle management of assigned program.
Effectively communicates the regulatory strategies, submission
plans and timelines; and impact assessments of trends, regulations
and changes related to assigned programs.
- Stays current with regulations / guidance's in Emerging Markets
for impact on drug development plans, registration and life-cycle
management to maximize the positive outcomes of the regulatory
applications and maintain registration compliance.
- Provides regulatory expertise on Emerging Markets for multiple
projects including one highly complex program, focused on
non-clinical and clinical aspects of registration and / or
post-marketing compliance and life cycle management.
- Assures ongoing efforts towards fulfilment of international
product approval conditions for late stage programs.
- Develops effective working relationships with Local Regulatory
Lead, Regional and Global Regulatory Team, Cross-functional Teams;
company's consultants and Business Partners.
- Provides regulatory input to the evaluation of new business
development opportunities for Emerging Markets.
- In coordination with local regulatory lead provides strategic
guidance / advice on emerging trends, regulations and changes, with
emphasis on those related to assigned program enabling proactive
approach and planning to future business needs.
- Supports preparation activities for meetings with Health
Authorities for the assigned program, as required. Interacts
directly with HA, as required. Represents Takeda Emerging Markets
in Health Authority meetings, as required. Effectively communicates
and manages meeting outcome and next steps, as required.EDUCATION,
EXPERIENCE AND SKILLS:
- BS degree in a scientific discipline; BA accepted based on
experience. Advanced degree preferred.
- Sound experience within the pharmaceutical industry and
including direct experience in regulatory affairs in development
and /or post-marketing phases.
- 4 years of directly related regulatory experience is
- Sound working knowledge of regulations and guidance's governing
drugs and biologics in development and life-cycle management for
emerging markets; and US and/EU (relevant to role), including
interaction with Health Authorities.
- Experience with external partners
- Leading cross-functional teams in regulatory submissions
- Generally strong in most and acceptable in all basic skill sets
such as oral and written communications, managing and adhering to
timelines, negotiation skills, integrity and adaptability.
- Able to demonstrate skill(s) in regulatory strategy such as
understanding broad concepts within regulatory affairs and
implications across the organization and globally; proactively
identifies regulatory issues; offers creative solutions and
strategies, including risk mitigation strategies.
- Generally strong in working well with others and within global
- Experience managing relationships with CROs and/or contractors
is desirable.This job posting excludes CO applicantsTRAVEL
- Willingness to travel to various meetings, including overnight
- Requires approximately up to 10-30% travel.WHAT TAKEDA CAN
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach ProgramsEmpowering Our People to ShineLearn
more at .#LI-JV1EEO 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.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, North Bergen , Manager or Senior Manager, Growth & Emerging Markets - GI/NS, Global Regulatory Affairs, Executive , North Bergen, New Jersey
Didn't find what you're looking for? Search again!