Associate Director/Director, Global Regulatory Affairs Development
Company: Takeda Pharmaceutical
Location: Brooklyn
Posted on: January 27, 2023
Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge. Job Description Associate
Director/Director Global Regulatory Affairs - Global Regulatory
Lead - Rare Genetics and Hematology - Cambridge, Massachusetts or
Zurich, SwitzerlandJob DescriptionThe Associate Director/Director
Global Regulatory Affairs, Rare Genetics and Hematology, is
responsible for providing strategic regulatory guidance in the
global development of rare diseases leading the Global Regulatory
Team(s) (GRTs) in the development and implementation of regulatory
strategies and operational plans to achieve marketing approvals in
all major markets. Represents the global regulatory function at
Global Product Teams (GPT) and at the Therapeutic Area Unit (TAU)
as required. OBJECTIVES:
- Defines, develops, and leads global strategies to maximize
global regulatory success towards achievement of program objectives
for complex and/or multiple projects.
- Provides strategic regulatory advice on the clinical
development of gene therapy products, including interpretation of
final and draft regulatory guidance regarding manufacturing
considerations, specific disease therapeutic targets (eg,
neurodegenerative diseases), and sameness of gene therapy products
under the orphan drug regulations
- Keeps abreast of new developments in rare diseases development
maintaining oversight on the rapidly evolving regulatory landscape
and advancing innovations in the development of rare disease,
products.
- Understands and interprets scientific data as it relates to
regulatory requirements and strategy for assigned projects and
provides knowledge and expertise to guide team in established and
building appropriate regulatory strategy.
- Is a leader both in the department and within R&D,
contributing to cross-functional initiatives and influencing the
field as applicable. Represents Takeda as applicable in
industry/regulatory forums to lead regulatory
innovation.ACCOUNTABILITIES:
- The Associate Director/Director will be responsible for complex
or highly complex or multiple projects. Leads the Global Regulatory
Teams (GRTs) and applicable sub-working groups, such as the Label
Working Group, and represents GRTs at project team meetings.
Defines strategies and provides tactical guidance to teams and
collaborates cross-functionally to ensure the global regulatory
strategy is updated and executed, ensuring global regulatory
compliance and/or oversees direct reports or junior staff.
- Ensures project team colleagues, line management, and key
stakeholders are apprised of developments that may impact
regulatory success, exercising sound judgement and communicating in
a professional and timely manner.
- Proactively anticipates risks and responsible for developing
solutions to identified risks and discussing with team and
management; understands probabilities of technical success for the
solutions.
- Accountable for all US FDA submissions and approvals of
project(s) of responsibility or oversees direct reports
responsible. The Associate Director/Director will lead all
submission types.
- Direct point of contact with health authorities, leads and
manages FDA meetings. Manages direct reports or junior staff as
needed.
- Accountable for working with regulatory regional leads, other
functions and vendors to ensure global regulatory submissions are
provided to local Takeda affiliates in compliance with local
regulations and to maintain compliance for products.
- Oversee vendor responsibility for regulatory activities and
submissions related to projects within scope.
- Participates with influence in or leads departmental and
cross-functional taskforces
- and initiatives.
- Serves as lead regulatory reviewer in due diligence for
licensing opportunities.
- Partner with global market access colleagues to Lead
interactions with joint regulatory/health agency/HTA bodies on
product specific value evidence topics, as applicable.
- Monitor and anticipate trends that impact both the regulatory
and access environments to strengthen product development plan(s)
and adopt regulatory strategies in a timely manner.
- Responsible for demonstrating Takeda leadership
behaviorsREQUIREMENTS:
- Understanding of the regulatory framework for the clinical
development and manufacturing of gene therapy products leading to
global marketing authorizations. Ability to advice on applicable
regulations and guidance documents, including providing
interpretation of these governing documents by regulators as
experience is gained in practice.
- Keeps abreast of new developments in gene therapy and maintains
oversight on the rapidly evolving regulatory landscape and
advancing innovations in the development of gene therapy
products.
- Understands and interprets scientific data as it relates to
regulatory requirements and strategy for assigned projects and
provides knowledge and expertise to guide team in established and
building appropriate regulatory strategy.
- Strong oral and written communications, managing and adhering
to timelines, negotiation skills, integrity, and adaptability.
- Demonstrates acceptable skills with increasing independence in
the area of regulatory strategy such as understanding broad
concepts within regulatoryaffairs and implications across the
organization and globally; proactively identifies regulatory
issues; offers creative solutions and strategies, including risk
mitigation strategies.
- Must work well with others and within global teams.
- Able to bring working teams together for common
objectives.
- Acceptable and independent skills in the area of 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.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 Cambridge, MA Worker Type Employee Worker Sub-Type
Regular Time Type Full time
Keywords: Takeda Pharmaceutical, New York , Associate Director/Director, Global Regulatory Affairs Development, Executive , Brooklyn, New York
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