Global Regulatory Policy & Innovation - Labeling Lead
Company: Takeda Pharmaceutical
Location: Old Bridge
Posted on: July 31, 2022
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Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's Privacy Notice and Terms of Use. I further attest
that all information I submit in my employment application is true
to the best of my knowledge. Job Description About the role: At
Takeda, we are a forward-looking, world-class R&D organization
that unlocks innovation and delivers transformative therapies to
patients. By focusing R&D efforts on four therapeutic areas and
other targeted investments, we push the boundaries of what is
possible in order to bring life-changing therapies to patients
worldwide. Join Takeda as an Global Regulatory Policy & Innovation
- Labeling Lead How you will contribute: You will work Lead and
work with regional regulatory affairs experts on a broad set of
regulatory policy and innovation initiatives, with a focus on
labeling reform and e-labeling. 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, and partner on global
regulatory strategies and objectives. Provide global regulatory
intelligence and data-driven insights (with a focus on US and EU
regions) regarding product labeling, label compliance,
labeling-related competitive intelligence, and other primary
research objectives. Coordinate with regulatory compliance function
to ensure timely implementation of upcoming and possible regulatory
changes for Takeda marketed products Provide strong partnership
support and policy insight for a wide range of Takeda regulatory
and product functions, including global regulatory product labeling
and packaging Lead external engagement strategy for multiple
regulatory policy and regulatory science areas, including
regulatory product labeling and packaging, electronic labeling
pilots, labeling reform, and real world data integration within
product labeling. Maintain global visibility and regulatory
intelligence regarding developments and opportunities within
pharmaceutical product labeling and packaging, among other areas;
conduct assessments and provide insights to internal teams as
appropriate. Develop and explore innovative strategies for
regulatory intelligence, and regulatory innovations regarding data,
product labeling, and product development, in coordination with
GRPI and GRA stakeholders. 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. Responsible for demonstrating Takeda Leadership
Behaviors Minimum Requirements/Qualifications: 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 preferred but not required.
[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/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 Takeda can offer
you: Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan Health & Wellness programs
including onsite flu shots and health screenings Generous time off
for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable
contributions Family Planning Support Flexible Work Paths Tuition
reimbursement More about us: At Takeda, we are transforming patient
care through the development of novel specialty pharmaceuticals and
best in class patient support programs. Takeda is a patient-focused
company that will inspire and empower you to grow through
life-changing work. Certified as a Global Top Employer, Takeda
offers stimulating careers, encourages innovation, and strives for
excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our teams are united by an
unwavering commitment to deliver Better Health and a Brighter
Future to people around the world. In accordance with the CO Equal
Pay Act, Colorado Applicants Are Not Permitted to Apply. Absent an
approved religious or medical reason, all US field-based employees
must be fully vaccinated for COVID-19, as a condition of
employment. 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, MAUSA - DC -
WashingtonWorker Type EmployeeWorker Sub-Type RegularTime Type Full
time
Keywords: Takeda Pharmaceutical, Elizabeth , Global Regulatory Policy & Innovation - Labeling Lead, Other , Old Bridge, New Jersey
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