Manager or Senior Manager, Growth & Emerging Markets - GI/NS, Global Regulatory Affairs
Company: Takeda Pharmaceutical
Posted on: May 13, 2022
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Are 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
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
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.
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
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
4 years of directly related regulatory experience is desirable.
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
This job posting excludes CO applicants
Willingness to travel to various meetings, including overnight
Requires approximately up to 10-30% travel.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com .
Takeda 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.
Keywords: Takeda Pharmaceutical, Newark , Manager or Senior Manager, Growth & Emerging Markets - GI/NS, Global Regulatory Affairs, Executive , Newark, New Jersey
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