Sr. Director, Team Lead GI & NS
Company: Takeda Pharmaceutical
Location: Browns Mills
Posted on: November 26, 2022
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to the best of my knowledge.Job Description
- Defines, develops and leads regional strategies to maximize
regulatory and patient access to enable patient access to
meaningful medicines in alignment with program objectives.
- Effectively communicates objective assessments of the
likelihood of success of these regulatory strategies. Provides
strategic and tactical advice and guidance to teams to achieve
timely and efficient conduct of development programs while
maintaining full compliance with applicable regulatory
- Provides regulatory expertise for multiple projects or for one
highly complex project (e.g. global project with multiple
indications and presentations), focused on non-clinical and
clinical aspects of drug development and / or post-marketing
compliance and life cycle management. -
- Provides leadership and development for multiple direct reports
for the design and execution of regional regulatory strategies in
collaboration with their regional counterparts, GPT colleagues, and
value and access teams.
- Act as deputy to the Region regulatory head, attending internal
or external leadership team meetings, as appropriate.
- Provides direction to senior leadership and teams on emerging
trends, regulations and changes, with emphasis on those related to
therapeutic areas and/ or region of responsibility enabling
proactive approach and planning to future business
- Manages and oversees interactions with EMA and national health
authorities (and HTAs jointly with value and access team in context
of parallel consultation) in the Europe Union and European Economic
Area for all products in defined therapy area scope. Provides
interpretation to the business.
- Oversees regional regulatory leads and staff responsible for
ensuring regional regulatory strategies are written, reviewed and
executed according to plan and appropriately capture patient access
requirements. May also act as a Regulatory lead. Provide strategic
and tactical advice and guidance to allow the timely and efficient
conduct of development programs, while maintaining full compliance
with applicable regulatory requirements.
- 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/HTA bodies on value and evidence topics and to support
health authority decision making. Collaborate with EUCAN on value
and evidence generation and relative effectiveness topics to
support patient access.
- Collaborates with Takeda counterparts and IBT to ensure a
global and / or regional regulatory strategy is created and
executed upon for all projects within scope of responsibility.
Identifies regulatory requirements and trends and provides
regulatory guidance, and expertise to global project team and/or
higher governance bodies in these areas.
- Directs and oversees multiple projects, generally has regional
oversight for compounds in a minimum of one disease area.
- Oversees and accountable for working with other RA functions
and/or vendor to ensure that regulatory submissions and approvals
are achieved on schedule within area of responsibility. Understands
importance of regulatory documents for value and access discussions
and partners with access functions to support access
- In collaboration with global colleagues, works to resolve
regional critical conflicts in global regulatory strategies and
oversee critical deliverables outside of region as agreed within
the global regulatory strategy. - Approves regional regulatory
strategies and authors for more complex regulatory strategies as
needed; oversee execution, generally delegates to staff and / or
- Supervises multiple direct reports. - Manages, trains and
provides oversight for staff day-to-day activities.
- Leads critical interactions/meetings with senior
representatives of appropriate health authorities; delegates to
staff, as appropriate, for other health authority
- Lead regulatory reviewer in due diligence for licensing
- Proactively builds/strengthens external stakeholder (Regulatory
Agency, external experts, industry organizations, etc)
contacts/influence to achieve Takeda strategic goals and
- Identifies regulatory requirements and trends across
therapeutic area(s) of responsibility, and provides regulatory
guidance, and expertise to global development team and/or higher
governance bodies in these areas.
- Manages personnel within group to ensure coverage for project
and therapy area(s) responsibilities; Elevates needs when
- Presents to senior management.EDUCATION, BEHAVIOURAL
COMPETENCIES AND SKILLS: -
- BSc. Advanced scientific related degree preferred; 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
- Thorough knowledge of regulations and guidance's governing
drugs and biologics in all phases of development in the US and/or
EU (relevant to role), with a good understanding of basic
regulatory requirements in emerging markets. Understanding of
evidence requirements beyond the regulators (e.g. HTA bodies).
- 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.
- Preferred experience in managing multiple filings; or managing
multiple programs in closely related development area; global
involvement also preferred. - Must be able to provide guidance in
interpreting regulatory regulations and guidelines. Strong
leadership, communication (written and verbal), and management
skills are required.
- Excellent written, communication, project management and
presentation skills (articulate and persuasive). Pro-active,
energetic, self-assured professional with high personal integrity
and ability to develop good interpersonal relationships
- Analytical, strategic thinker with proven leadership ability
that demonstrates professionalism and establishes respect with
excellent people management skills. - Demonstrated ability to
develop others in the area of regulatory strategy, including as
understanding broad concepts within regulatory affairs and
implications across the organization and globally; proactively
identifies regulatory issues; offering creative solutions and
strategies, including risk mitigation strategies.
- Ability to influence others, at all levels of the organization,
without direct hierarchal authority, and affect change across
organizational boundaries. - Ability to collaborate effective with
peers, within global teams and in communicating with senior
- Must be strong leader that creates vision for group. - Inspires
and motivates group. - Takes stand on important issues in
productive, respectful way.
- Preferred experience in managing multiple personnel for
multiple years as well as experience managing relationships with
CROs and/or contractorsLocationsZurich, SwitzerlandWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Camden , Sr. Director, Team Lead GI & NS, Executive , Browns Mills, New Jersey
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