Associate Director, Global Labeling Operations
Company: Takeda Pharmaceutical
Location: Harrisburg
Posted on: May 13, 2022
Job Description:
By clicking the "Apply" button, I understand that my employment
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information I provide in my application will be processed in line
with Takeda's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionOBJECTIVES/PURPOSE
- The Global Labeling Regulatory Operations Lead will provide
strategic and tactical labeling operations expertise to teams while
ensuring compliance with applicable regulatory requirements related
to submission of labeling, labeling artwork development, and
associated processes -
- Responsible to work with the Global Labeling Leads, Global
Regulatory Leads, Local Regulatory Leads, Quality and Supply Chain
Management to ensure timely and accurate labeling for new product
launches and product changes. -ACCOUNTABILITIES -Leveraging your
subject matter expertise and knowledge of US and/or EU labeling
requirements, you will: -
- Serve as regulatory expert for US and/or EU 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 systems - - -Submission Labeling -
- Manage Regulatory Labeling Submissions files to ensure they are
submission ready -
- Stay current with regulations / guidance tied to US/EU 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 Device Labeling Lead and Device Labeling Ops to
ensure seamless support of drug/device combination products - -
-Artwork/Mock-Ups -
- Lead the development of artwork files including the Takeda
Artwork Management system, ensuring the successful preparation,
submission availability of packaging artwork files -
- Communicates the regulatory driven implementation guidance of
packaging artwork files to Global Supply Chain to ensure and 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; and impact assessments of trends, regulations
and changes related to labeling -
- Communicate the regulatory driven implementation guidance of
packaging artwork files to Global Supply Chain to ensure and timely
change of packaging components - -
- Be responsible for working with suppliers for translation
services where required - -Other -
- 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 devices -
- 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 US/EU
Labeling KPIs are achieved; and labeling operation deliverables are
completed consistently and in accordance with - market regulations
and Takeda's standard operating procedures -CORE ELEMENTS RELATED
TO THIS ROLE
- Excellent communication, organizational, and team collaboration
skills -
- Must work effectively with global work associates,
demonstrating strong interpersonal skills combined with cultural
sensitivity -
- Ability to interact effectively at high levels, between
customers and suppliers, and to manage and resolve issues and to
provide effective feedback -
- Must be able to handle multiple projects simultaneously while
maintaining high quality results. -
- Must provide and implement innovative solutions to unique
situations. -
- Must be able to recognize potential conflict and escalate when
necessary -
- Effectively navigate the changing external and internal
environment and lead others through change by creating and
inspiring and engaging workplace -
- Demonstrate leadership presence and confidence with the ability
to with teams in a matrixial operating model - -DIMENSIONS AND
ASPECTS - -Technical/Functional (Line) Expertise (Breadth and depth
of knowledge, application and complexity of technical knowledge) -
-
- Detailed understanding of US and/or EU (relevant to role)
pharmaceutical drug and device development, combination product
maintenance, and global regulations and operations pertaining to
labeling -
- Ability to manage operational responsibilities across
disciplines - -Leadership (Vision, strategy and business alignment,
people management, communication, influencing others, managing
change) - -
- May provide direction, and/or strategic guidance, to junior
team members and / or strategic business partners and CROs, as
required, to support the scope of US/EU Labeling Operations project
work -
- Work with the Head of Global Labeling Operations and Excellence
and strategic business partners to ensure that labeling operations
tasks are executed consistently and compliantly with Takeda's
standard operating procedures -
- Good leadership skills including change management, people
development, strategic thinking and influencing -Decision-making
and Autonomy (The capacity and authority to make organizational
decisions, autonomy in decision-making, complexity of decisions,
impact of decisions, problem-solving) -
- Ability to strategize, communicate and resolve issues
independently -
- Self-motivated, self-starter with the ability to work
independently and in a team with a flexible mindset -
- Independently manage product workload and coordinates with
stakeholders to ensure timely completion of product work
deliverables - -
- Forward thinker with the ability to recommend, influence and
implement organizational change and continuous innovation
-Interaction (The span and nature of one's engagement with others
when performing one's job, internal and external relationships) -
- Highly cross functional role working with many levels of
leadership across Takeda - -
- Develops effective working relationships with Global Labeling
Lead, Local Regulatory Lead, Regional and Global Regulatory Team,
Cross-functional Teams; company's consultants and Business Partners
-Innovation (The required level of scientific knowledge, knowledge
sharing, innovation and risk taking) -
- Ability to identify and take risks implementing innovative
solutions, accelerating time to market -
- Ability to problem-solve, negotiate solutions, think
strategically, and operate in a fast-paced environment -
- High understanding of systems related to labeling operations,
technology, Regulatory Information Management -
- High understanding of Labeling, Regulatory, Supply Chain and
Local Market -Complexity (Products managed, mix of businesses,
internal and/or external business environment, cultural
considerations) -
- Ability to manage operational responsibilities across
disciplines, regions and internal and external customers -
- Ability to understand broad concepts within regulatory affairs
and implications across the organization and globally -
- Defines and resolves complex issues where fundamental
principles do not clearly apply or where data appear to conflict.
Recommendations require independent and innovative thinking.
Solutions often require using resources outside the organization
for data, advice, etc. - -
- Decisions impact across the organization and key
products/markets - -EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
-
- 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. -
- 8 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 for US and/or EU
(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. - -
- In accordance with the CO Equal Pay Act, -Colorado Applicants
Are Not Permitted to Apply.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.EEO
StatementTakeda 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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Harrisburg , Associate Director, Global Labeling Operations, Executive , Harrisburg, Pennsylvania
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