Manager/Sr. Manager, Global Labeling Operations
Company: Takeda Pharmaceutical
Location: Brooklyn
Posted on: January 27, 2023
Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge. Job Description 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.The
Global Labeling Regulatory Operations role will provide tactical
labeling operations expertise to teams while ensuring compliance
with applicable regulatory requirements related to submission of
labeling, labeling artwork development, and associated processes.
Working with the Global Labeling Leads, Global Regulatory Leads,
Local Regulatory Leads, Quality and Supply Chain Management you
will ensure timely and accurate labeling for new product launches
and product changes.Leveraging your subject matter expertise and
knowledge of US labeling requirements, you will:
- Serve as regulatory expert for product labeling components
(submission, packaging artwork and mock ups) to ensure that
regulatory labeling requirements are met for assigned products
- Maintain project timelines and collaborating with the Global
Labeling Lead driving on time delivery of operational pre and post
approval labeling activities
- Manage labeling in Document Management/Quality
Management/Artwork Management systemsSubmission Labeling
- Manage Regulatory Labeling Submissions files to ensure they are
submission ready
- Stay current with regulations / guidance tied to labeling and
packaging artwork for impact on new product introductions and life
cycle management of products already on market
- Manage Electronic Labeling (i.e. Structured Product Labeling)
with the support of external vendors
- Coordinate with Labeling Strategy and Labeling Ops colleagues,
as appropriate, to ensure seamless support of drug and drug/device
combination productsArtwork/Mock-Ups
- Lead the development of artwork files including the Takeda
Artwork Management system, ensuring the successful preparation, and
submission availability, of packaging artwork files
- Communicates the regulatory driven implementation guidance of
packaging artwork files to Global Supply Chain to ensure timely
change of packaging components for assigned products
- Effectively communicates regulatory strategies tied to the
packaging artwork and the impact of labeling changes on submission
plans and timelines; as well as impact assessments of trends,
regulations and changes related to labeling
- Communicates the regulatory driven implementation guidance of
packaging artwork files to Global Supply Chain to ensure timely
change of packaging components
- Be responsible for working with suppliers for translation
services where requiredOther
- Be responsible for coordinating and providing Regulatory
Labeling Assessments into the quality management system for any
changes impacting product labeling
- Define, develop and execute Global Labeling Operations
strategies to maximize regulatory success towards achievement of
program objectives across pipeline, including drugs, devices and
drug/device combination products
- Participate in cross-functional and GRA initiatives to
represent Labeling needs related to technology, systems and
Regulatory Information Management to ensure the teams meet their
goals and objectives
- Partner and coordinate with vendors to ensure that Labeling
KPIs are achieved; and labeling operation deliverables are
completed consistently and in accordance with market regulations
and Takeda's standard operating procedures Minimum
Requirements/Qualifications:
- Bachelor's degree preferred, equivalent combination of
education, training, and relevant experience may be considered in
place of the education and experience stated above. All employees
must read, write and speak fluent English.
- 6 years of directly related experience is desirable. This is
inclusive of thorough regulatory experience, supply chain, Local
Market or related experience in both development and /or
post-marketing phases.
- Strong operational regulatory and business experience,
including knowledge of regulations and guidance governing drugs and
biologics labeling in all phases of development (relevant to
role)
- Preferred expertise in packaging regulations and processes
involved in the generation and review of labeling
artwork/mockup
- Knowledge of the requirements for artwork in US and/or EU
(relevant to role). Experience in the preparation and submission of
artwork using artwork management systems (e.g. BLUE, Webcenter)
beneficial
- Ability to proactively identify regulatory issues; offers
creative solutions and strategies, including risk mitigation
strategies. What 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 reimbursementMore 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.This position is
currently classified as "hybrid" in accordance with Takeda's Hybrid
and Remote Work policy.Base Salary Range: $101,500- $145,000 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.The final salary offered for this position may
take into account a number of factors including, but not limited
to, location, skills, education, and experience.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 Massachusetts - Virtual Worker Type Employee Worker
Sub-Type Regular Time Type Full time
Keywords: Takeda Pharmaceutical, New York , Manager/Sr. Manager, Global Labeling Operations, Executive , Brooklyn, New York
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