Senior Manager / Manager, Growth & Emerging Markets - GI/NS, Global Regulatory Affairs
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: June 15, 2022
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information I provide in my application will be processed in line
that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionPOSITION
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.
- 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.TRAVEL REQUIREMENTS:
- Willingness to travel to various meetings, including overnight
- Requires approximately up to 10-30% travel.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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Cherry Hill , Senior Manager / Manager, Growth & Emerging Markets - GI/NS, Global Regulatory Affairs, Executive , Cherry Hill, New Jersey
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