Associate Director, Global Labeling Operations

Company: Takeda Pharmaceutical
Location: Medford
Posted on: May 12, 2022

Job Description:

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Job Description
OBJECTIVES/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 s trong interpersonal skills combined with cultural sensitivity

Ability to interact effectively at high levels, between customers and suppliers, and to manage and resolve i ssues 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

Decis ion-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 think er 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:
B achelor's degree preferred, e quivalent 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 e xpertise in packaging regulations and processes involved in the generation and review of labeling artwork/mockup

K nowledge 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 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, Medford , Associate Director, Global Labeling Operations, Executive , Medford, Massachusetts