Senior Manager, Growth & Emerging Markets, Global Regulatory Affairs, Rare Diseases
Company: Takeda Pharmaceutical
Location: Hoboken
Posted on: May 10, 2022
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Job Description:
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 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 Cambridge office. Here,
everyone matters and you will be a vital contributor to our
inspiring, bold mission. As a Senior Manager / 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: POSITION
OBJECTIVES: 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
management. Help the team leader to provide direction, support,
mentoring, and strategic guidance to other team members to support
scope of project work, when applicable. POSITION ACCOUNTABILITIES:
Responsible for demonstrating Takeda leadership behaviors. Defines,
develops and leads Growth and--Emerging Markets strategies to
maximize regulatory success towards achievement of program
objectives. 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 countries 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, as required.
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
project work. 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 making. 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 phases. 8+ years of directly related
regulatory experience is desirable. 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
globally; 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. TRAVEL REQUIREMENTS:
Willingness to travel to various meetings, including overnight
trips. Requires approximately up to 10-30% travel WHAT TAKEDA CAN
OFFER YOU: 401(k) with company match and Annual Retirement
Contribution Plan Tuition reimbursement Company match of charitable
contributions Health & Wellness programs including onsite flu shots
and health screenings 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 . No
Phone Calls or Recruiters Please. #LI-VM EEO Statement 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.
Locations Massachusetts - Virtual Worker Type Employee Worker
Sub-Type Regular Time Type Full time
Keywords: Takeda Pharmaceutical, Hoboken , Senior Manager, Growth & Emerging Markets, Global Regulatory Affairs, Rare Diseases, Executive , Hoboken, New Jersey
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