Director/Senior Director, Global Regulatory Lead - Rare Diseases (Gene Therapy)
Company: Takeda Pharmaceutical
Posted on: January 26, 2023
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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 Director/Senior Director, Global Regulatory
Lead in our Cambridge office. Here, everyone matters and you will
be a vital contributor to our inspiring, bold mission. As a
Director/Senior Director working on the Global Regulatory Affairs
Development team, you will be empowered to l ead the global
regulatory team to develop strategies to maximize regulatory
success towards achievement of program objectives, and a typical
day will include: 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 gene therapy and maintains
oversight on the rapidly evolving regulatory landscape and
advancing innovations in the development of gene therapy
- 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.
- The Director/Senior 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
- Accountable for all US FDA submissions and approvals of
project(s) of responsibility or oversees direct reports
responsible. The Director/Senior Director will lead all submission
- Direct point of contact with health authorities, leads and
manages FDA meetings. Manages direct reports or junior staff as
- 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 task-forces and initiatives.
- Lead regulatory reviewer in due diligence for licensing
- 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 behaviors
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- BSc or Advanced Degree, preferred. BA accepted.
- 10+ years of pharmaceutical industry experience. This is
inclusive of 8 years of regulatory experience or combination of 6+
years regulatory and/or related experience.
- 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.
- Preferred experience in reviewing, authoring, or managing
components of regulatory submissions.
- Solid working knowledge of drug development process and
regulatory requirements. Knowledge of FDA, EU, Canada, ROW and
post-marketing a plus.
- 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 regulatory affairs and implications across the
organization and globally; proactively identifies regulatory
issues; offers creative solutions and strategies, including risk
- Must work well with others and within global teams.
- Able to bring working teams together for common
- 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. PHYSICAL
- Manual dexterity required to operate office equipment (ie
computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while
- Willingness to travel to various meetings, including overnight
- Requires approximately up to 10-30% travel.WHAT TAKEDA CAN
- 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 .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, Cambridge , Director/Senior Director, Global Regulatory Lead - Rare Diseases (Gene Therapy), Executive , Cambridge, Massachusetts
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