Senior Manager, EUCAN Regulatory Lead Neuroscience
Company: Takeda Pharmaceutical
Posted on: November 25, 2022
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to the best of my knowledge.Job DescriptionAre you looking for a
patient-focused, innovation-driven company that will inspire you
and empower you to shine? Join us as a Senior Manager, EUCAN
Regulatory Lead Neuroscience based in Zurich. Here, you will be a
vital contributor to our inspiring, bold mission.The Senior
Manager, EUCAN Regulatory Lead Neuroscience will be responsible
- Providing strategic and tactical regional regulatory advice and
guidance to teams to achieve timely and efficient conduct of
development programs while maintaining full compliance with
applicable regulatory requirements.
- Effectively communicating objective assessments of the
likelihood of success of these regulatory strategies.
- Providing regulatory expertise and strategic focus for assigned
development projects and /or marketed product life cycle
- Monitoring and informing on emerging trends, regulations and
changes, with emphasis on those related to project areas and/ or
region of responsibility enabling proactive approach and planning
to future business requirements
- Being the primary EMA contact for project(s)/products of
- Informing the business and manages interactions with EMA and
national health authorities and HTAs (jointly with value and access
team in in context of parallel consultation) in the Europe Union
and European Economic Area for specific
- Leads the regulatory working team for own region and represents
region as needed at project team and ensures regional regulatory
lifecycle management strategy and submission planning written and
executed according to plan - or oversees if delegated to staff
- Partner with the regional/LOC RA and market access colleagues
to understand market access and reimbursement topics and support
opportunities to drive consolidated inputs into regional product
- For the project(s)/product(s) of responsibility, collaborates
with Global and Regional colleagues for the authoring of global
regulatory strategies and ensures own critical deliverables as
agreed within the global regulatory strategy and planning are
- Where responsibility includes a marketed product, provides
oversight to ensure regulatory compliance, including oversight of
the product related data in the registration database.
- Accountable for working with other RA functions and/or vendor
to ensure that regulatory submissions and approvals are achieved on
schedule within region of responsibility (e.g. EMA submissions for
- Understands importance of regulatory documents for value and
access discussions and partners with access functions to support
access applications as needed.
- Identifies relevant regional regulatory requirements and
provides regulatory guidance, and expertise to internal team on the
assigned project(s) of responsibility. Authors and reviews global
and/ or regional regulatory strategies as well as executes
day-to-day activities for projects.
- May include some oversight of vendor activities.
- Leads and manages meetings in own region (e.g. EMA for Europe)
and have awareness of relevant regulatory agency meetings scheduled
with other regions (such as FDA) or Local Takeda affiliates for
project(s)/product(s) of responsibility.
- May be called upon to support in due diligence for licensing
opportunities, development and /or marketed product
- Builds/strengthens external stakeholder (Regulatory Agency,
external experts, industry organizations, etc) contacts/influence
to support Takeda strategic goals and objectives.
- Identifies regulatory requirements across area(s) of
responsibility, and provides regulatory guidance, and expertise to
global development team and /or Region in these areas.
- Identifies and proposes solutions to the management of resource
gaps for areas of responsibility.EDUCATION, BEHAVIOURAL
COMPETENCIES AND SKILLS:
- BS degree or equivalent in science; advanced degree
- Experience within the pharmaceutical industry, including direct
experience in regulatory affairs in development and /or
- Working knowledge of regulations and guidances governing drugs
and biologics in development, including post-marketing in the US
and/or EU (relevant to role). A good understanding of basic
regulatory requirements in emerging markets is a plus. Awareness of
evidence requirements beyond the regulators (e.g. HTA bodies)
- Understands and interprets complex scientific issues and
capability to relate to regulatory requirements and strategy.
- Proven regulatory submissions capability in a region (Europe,
- Generally strong in most and acceptable in all basic skill sets
such as oral and written communications, managing and adhering to
timelines, negotiation skills, integrity and adaptability.
- Able to demonstrate 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.
- Generally strong in working well with others and within global
- Effective manager who is able to bring working teams together
for common objectives.
- Experience managing relationships with CROs and/or contractors
preferred.WHAT TAKEDA CAN OFFER YOUAt Takeda, we are transforming
the pharmaceutical industry through our R&D- driven market
leadership and being a values-led company. To do this, we empower
our people to realize their potential through life-changing work.
Certified as a Global Top Employer, we offer stimulating careers,
encourage innovation, and strive for excellence in everything we
do. We foster an inclusive, collaborative workplace, in which our
global teams are united by an unwavering commitment to deliver
Better Health and a Brighter Future to people around the
world.Empowering Our People to ShineDiscover more at
takedajobs.comAt our heart are committed colleagues. We offer
interested people numerous opportunities and strongly believe in,
and promote, diversity, equity and inclusion. As a company we offer
roles based on merit, welcoming candidates of any gender, age,
religious belief, race or ethnic origin or disability. Our team is
growing and for this we need bright minds with creativity and
flexibility - what talent do you have? LocationsZurich,
SwitzerlandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull
Keywords: Takeda Pharmaceutical, Yonkers , Senior Manager, EUCAN Regulatory Lead Neuroscience, Executive , Thornwood, New York
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