Global Regulatory Policy & Innovation - Labeling Lead
Company: Takeda Pharmaceutical
Location: Syosset
Posted on: May 12, 2022
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Job Description:
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Job Description
OBJECTIVES/PURPOSE
Provide global regulatory intelligence (wiht a focus on US and EU
regions) regarding product labeling, label compliance,
labeling-related competitive intelligence, and other primary
research objectives.
Work closely with GRA-labeling function and product teams to
provide real-time therapeutic area and product-specific impact
analysis of changes in labeling and product packaging regulations
and laws.
Coordinate with regulatory compliance function to ensure timely
implementation of upcoming and possible regulatory changes for
Takeda marketed products.
Provide timely updates and presentations on identified trends and
opportunities in labeling regulations within the US, EU, Japan,
China, and emerging markets.
Lead and work with regional GRPI experts on external regulatory
policy and innovation initiatives involving labeling reform and
e-labeling.
ACCOUNTABILITIES
Accountable for regulatory intelligence - including monitoring,
tracking, analysis, and reporting - of existing and emerging
regulations concerning product labeling and packaging.
Accountable for coordination with Regulatory Compliance and
Labeling Function to alert and provide context, analysis and
guidance regarding global labeling regulations.
Coordinate with Global Regulatory Policy and Innovation colleagues
on improving and accelerating regulatory intelligence systems,
processes, and alerts improvements.
Lead and support for development and execution on external policy
strategy regarding labelling and electronic labelling within the
US, EU, Japan, China, and emerging markets.
Support and lead GRA and R&D participation in US regional
committees to drive effective networking and representation to
ensure a one voice policy.
Contribute and lead, where appropriate, to the development and
implementation of appropriate systems, processes and standards
within GRPI, US GRPI, GRA and across Takeda as assigned.
Partner with Government/Public Affairs to understand and monitor
evolving trends for Access requirements regionally, work with
internal stakeholders to identify opportunities/threats and
advocate Takeda's positions externally.
Maintain consistent oversight of deliverables. Keep GRA management
and all internal customers, partners and stakeholders abreast of
progress and provide interim updates on ongoing activities and
current initiatives. Ensure issues are escalated when needed and
encourage resolution at the appropriate level.
Lead routine and ad hoc meetings within function and
cross-functionally.--- Presents to senior management as
relevant.
Responsible for demonstrating Takeda Leadership Behaviors.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Comprehensive understanding of the pharmaceutical industry (e.g.,
clinical development, the prescription drug distribution process,
etc), with a focus on regulations and laws pertaining to drug
labelling and packaging.
Strong understanding of US and EU drug regulations, EMA / FDA
structure and processes, and active/emerging issues regarding
regulatory labelign.
Familiariy with regulatory intelligence data sources and platforms
(e.g., Cortellis) that can be utilized within key regions of
interest (US, EU, Japan, China, and Emerging Markets)
Leadership
Demonstrated ability to work across functions, regions and
cultures
Enterprise level leadership with the ability to inspire, motivate
and drive results
Excellent communicator, able to persuasively convey both ideas and
data, verbally and in writing
Proven skills as an effective team player who can engender
credibility and confidence within and outside the company
Ability to distil complex issues and ideas down to simple
comprehensible terms
Executive leadership presence and confidence
Embraces and demonstrates a diversity and inclusion mindset and
role models these behaviors for the organizaiton
Decision-making and Autonomy
Broad decision making responsibilities: Ability to make highly
complex decisions that impact the enterprise
Accountable for decision making for designated function
Ability to seek diverse input from multiple constituents and
stakeholders to drive innovative solutions
Ability to incorporate feedback and ensure decisions are made
swiftly to yield flawless execution
Accountable for designing and implementing vision and strategy for
designated scope
Interaction
Effectively navigates the changing external and internal
environment and leads others through change by creating and
inspiring and engaging workplace
Ability to effectively implement R&D's partnership strategy
Effectively represent Takeda in High-level negotiations with the
ability to resolve conflict in a constructive manner
Innovation
Visionary and forward thinking with the ability to influence and
effectively drive organizational change and continuous
innovation
Comfortable challenging the status quo and bringing forward
innovative solutions
Ability to take risks implementing innovative solutions,
accelerating time to market
Complexity
Ability to work in a global ecosystem (internal and external) with
a high degree of complexity
Breadth of knowledge required across therapeutic areas,
indications, and/or modalities
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BS/MS - PhD, JD, MD, or equivalent graduate education strongly
preferred. -Proven track record working with a major regulatory
agency, specific experience in government affairs or policy is also
desired.
[Director]: A minimum of 10 years of pharmaceutical industry
experience. This is inclusive of 8 years regulatory experience or a
combination of 10 years regulatory and o/or related experience in
both development and post-marketing phases.
[Associate Director]: A minimum of 5 years of pharmaceutical
industry experience. - This is inclusive of 3 years regulatory
experience or a combination of 5 years regulatory and/or related
experience in both development and post-marketing phases.
Strong knowledge of regulations and guidance governing drugs and
biologics labeling in all phases of development, including
post-marketing, in the US and EU, with a good understanding of
basic regulatory requirements in other global markets (Japan,
China) and emerging markets. Sound knowledge of intelligence tools
and methods.
Understands and interprets complex scientific issues across
projects and therapy area(s) of responsibility as it relates to
regulatory requirements, regulatory intelligence, policy and
strategy for the region.
Excellent collaboration/relationship building, strong influencing
and negotiation skills, integrity and adaptability. Outstanding
written and oral communication skills as well as managing and
adhering to timelines. Proven success at stakeholder engagement
across organizational levels and boundaries.
Must be strong communicator, and ability to explain complex
regulatory issues, trends, and strategies to a wide range of
stakeholders
Must be strong leader that creates vision for group. - Inspires and
motivates group. - Takes stand on important issues in productive,
respectful way. Able to mentor and develop skills of staff.
Experience managing relationships with CROs and/or contractors a
plus.
** Preference will be given to candidates with a remote location
near, and availability to work during the working hours of, the
corporate office in Boston, Massachusetts and Washington, DC.**
In accordance with the CO Equal Pay Act, -Colorado Applicants Are
Not Permitted to Apply.
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
Boston, MA
USA - DC - Washington
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, New Rochelle , Global Regulatory Policy & Innovation - Labeling Lead, Other , Syosset, New York
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