Senior Manager, Global Labeling Lead
Company: Takeda Pharmaceutical
Location: Park Ridge
Posted on: November 22, 2022
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
that all information I submit in my employment application is true
to the best of my knowledge.
--- Responsible for the development, maintenance, and
implementation of Company Core Data Sheets (CCDS) in line with
international standards and guidelines.
--- Provide strategic and tactical labeling expertise to teams
while ensuring compliance with applicable regulatory
--- Serve as the regulatory expert for labeling on the global
Regulatory Affairs (RA) Subteam to ensure that regulatory labeling
requirements are met for assigned products
--- Leads cross functional teams to develop and update CCDS and
other key global labeling documents (i.e. CCDS Working Team)
--- In coordination with Global Labeling Oversight Committee (GLOC)
Chair, manages review and approval of CCDS/resolution of labeling
issues with the relevant GLOC
--- Evaluates risks associated with CCDS content and implementation
strategies, develops mitigation plans, and appropriately escalates
issues to Global Labeling management and the Global Regulatory
--- Recommends strategies and labeling language for inclusion in
key product labels (US PI, EU SmPC, JPI, others as appropriate),
consistent with the overall product strategy and information in the
CCDS, when available.
--- Provides information to Global Labeling Compliance, as
required, to support internal and external (i.e. Regulatory
Authority) requirements and support audits/inspections as a
labeling subject matter expert
--- Liaises with US Labeling Operations and EU Labeling Operations
to ensure labeling objectives and timelines are met
--- Analyzes relevant competitor labeling to ensure Takeda products
have the most competitive labeling possible; maintain awareness of
recent in-class approvals.
--- Remains current with global standards, initiatives by
regulatory authorities related to the CCDS and labeling, and
assures that Takeda processes conform to regulatory requirements.
Propose actions as needed.
--- Prepares/leads training and information sessions with GRA and
other functional areas to increase understanding and compliance
with internal and external labeling expectations and optimal
--- Establishes and manages cross-functional relationships to
ensure control and continuous improvement of global labeling
programs to meet business needs and regulatory requirements.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
--- BSc Degree, preferred. BA accepted. Advanced scientific degree
(MSc, PhD, or PharmD) preferred
--- 8+ years of pharmaceutical industry experience. This is
inclusive of 6 years of labeling experience or combination of 5+
years regulatory and/or related experience.
--- Understanding of scientific principles and regulatory/quality
systems relevant to drug development.
--- Knowledge of global standards and regulations related to CCDS
and Product Labeling (US PI and EU SmPC experience required, other
regional labels also preferred).
--- Strong oral and written communications, managing and adhering
to timelines, negotiation skills, integrity and adaptability.
--- Demonstrates problem-solving ability with ability to analyze
risk and make appropriate recommendations/decisions.
--- Must work well with others and within global teams.
--- Acceptable and independent skills in the area of regulatory
affairs such as understanding broad concepts within labeling and
implications across the organization and globally; proactively
identifies issues; offers creative solutions and strategies,
including risk mitigation strategies.
--- Responsible for demonstrating Takeda leadership behaviors.
--- Manual dexterity required to operate office equipment (i.e.
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.
Base Salary Range: $124,000 to $178,000, based on candidate
professional experience level. Employees may also be eligible for
Short-term and Long-Term Incentive benefits as well. Employees are
eligible to participate in Medical, Dental, Vision, Life Insurance,
401(k), Charitable Contribution Match, Holidays, Personal Days &
Vacation, Tuition Reimbursement Program and Paid Volunteer Time
Off. This posting is made in compliance with Colorado's Equal Pay
for Equal Work Act, C.R.S. - 8-5-101 et seq
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.
Massachusetts - Virtual
Full time #LI-Remote
Keywords: Takeda Pharmaceutical, Paterson , Senior Manager, Global Labeling Lead, Executive , Park Ridge, New Jersey
Didn't find what you're looking for? Search again!