Associate Director, Emerging Markets, Global Regulatory Affairs
Company: Takeda Pharmaceutical
Posted on: November 13, 2021
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knowledge.Job DescriptionAssociate Director, Growth and-Emerging
Markets, Global Regulatory Affairs, OncologyAre 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 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:POSITION
- 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.----------------------------POSITION
- Responsible for demonstrating Takeda leadership behaviors.
- Defines, develops and leads Growth and-Emerging Markets
strategies to maximize regulatory success towards achievement of
- 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
- 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
- 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 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
- 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
- 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
- Willingness to travel to various meetings, including overnight
- Requires approximately up to 10-30% travelEffective November 1,
2021, absent an approved religious or medical reason, all US
office-based and lab-based Takeda employees who work fully on-site
or in a hybrid model (as determined by Takeda) must be fully
vaccinated to work at a Takeda site or to engage with Takeda
colleagues or anyone else on behalf of Takeda. As of the same date,
absent an approved religious or medical reason, US field-based
employees, employees must be fully vaccinated in order to continue
in their current roles.- US employees who work at a Takeda
manufacturing facility, and those who work at a BioLife center or
BioLife lab, may be subject to different guidelines. Candidates are
encouraged to speak with their recruiter to seek further
information on the applicable guidelines for the Business
Unit/Function for which they have applied.WHAT TAKEDA CAN OFFER
- 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 .No Phone Calls or Recruiters Please.#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, Hackensack , Associate Director, Emerging Markets, Global Regulatory Affairs, Executive , Hackensack, New Jersey
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