Senior Manager/Associate Director Regulatory Emerging Markets - Oncology - Remote
Company: Takeda Pharmaceutical
Posted on: May 13, 2022
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Associate Director, Growth and -Emerging Markets, Global Regulatory
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 Senior Manager / Associate
Director, Emerging Markets, Global Regulatory Affairs in our
Here, everyone matters and you will be a vital contributor to our
inspiring, bold mission. As an Associate Director, Growth and
-Emerging Markets, Global Regulatory Affairs working on the
Research and Development team, you will be empowered to define,
develop and lead strategies to maximize regulatory success to
strengthen the product development plan, to enable patient access
and to achieve appropriate price and reimbursement in alignment
with program objectives, including all aspects of submission and
timely approval of investigational applications, market application
and life-cycle management. A typical will include:
Defines, develops and leads Growth and -Emerging Markets strategies
to maximize regulatory success to strengthen the product
development plan, to enable patient access and to achieve
appropriate price and reimbursement in alignment with program
objectives, including all aspects of submission and timely approval
of investigational applications, market application and life-cycle
Help the team leader to provide direction, support, mentoring, and
strategic guidance to other team members to support scope of
project work, when applicable.
Responsible for demonstrating Takeda leadership behaviors.
Defines, develops and leads Growth and -Emerging Markets strategies
to maximize regulatory success towards achievement of program
Independently manages, plans and directs all aspects for the
successful 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 at least one highly complex program, focused on
non-clinical and clinical aspects of drug development, 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.
Supports Access to Medicines initiatives to develop and implement
innovative patient access strategies.
Evaluates new business development opportunities for Emerging
Markets and / or participates on due diligence teams.
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.
Oversees interactions with Health Authorities in Emerging Markets
for all programs in defined Therapeutic Area scope.
Provides interpretation to the business, Global Product Lead and
other key stakeholders
Leads or supports preparation activities for meetings with Health
Authorities for the assigned program, as required.
Interacts directly with Health Authorities, as required.
Represents Takeda Emerging Markets in Health Authority meetings,
Effectively communicates and manages meeting outcome and next
steps, as required.
Has an established rapport with Global Health Authorities that
enables constructive exploratory discussions.
Mentors other team members, if required, to support scope of
Partner with the regional/LOC market access and LOC RA colleagues
to define the strategy for, and to lead and oversee joint
interactions with regional and national regulatory/Health Agency on
value and evidence topics and to support Heath Authority decision
EDUCATION, EXPERIENCE AND SKILLS:
BS degree in a scientific discipline; BA accepted based on
experience. Advanced degree preferred.
Extensive pharmaceutical industry experience. This is inclusive of
thorough regulatory experience or a solid combination of regulatory
and/or related experience in both development and post-marketing
8+ years of directly related regulatory experience is
Solid regulatory experience, including knowledge of regulations and
guidances governing drugs and biologics in all phases of
development for emerging markets and US and/or EU (relevant to
role) as well as leading
interaction with Health Authorities.
Preferred experience in managing multiple filings; or managing
multiple programs across therapy areas in closely related
development area; global involvement also preferred.
Must be able to provide guidance in interpreting regulatory
regulations and guidelines.
Must be able to formulate global regulatory strategy to achieve
competitive and accelerated product approvals.
Solid understanding and ability to interpret complex scientific
issues across projects and therapy area(s) of responsibility as it
relates to regulatory requirements and strategy.
Must be strong overall and able to train/develop staff in
regulatory strategy such as understanding broad concepts within
regulatory affairs and implications across the organization and
Proactively identifies regulatory issues; offers creative solutions
and strategies, including risk mitigation strategies.
Generally strong in all basic skills sets such as oral and written
communications, managing and adhering to timelines, negotiation
skills, integrity and adaptability.
Generally strong in working well with others, within global teams
and communicating with senior leadership.
Inspires and motivates group. Takes stand on important issues in
productive, respectful way.
Experience in managing personnel required; preferred experience in
managing multiple personnel for multiple years as well as
experience managing relationships with CROs and/or contractors.
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
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.
Massachusetts - Virtual
Keywords: Takeda Pharmaceutical, Newark , Senior Manager/Associate Director Regulatory Emerging Markets - Oncology - Remote, Executive , Millington, New Jersey
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