Manager, Global Labeling Operations

vor 1 Woche

Zürich, Zürich, Schweiz Takeda Pharmaceutical Vollzeit

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a
Manager, Global Labeling Operations, based in Zurich.


Here, you will be a vital contributor to our inspiring, bold mission.

Objective/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
  • Working with 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.

Accountabilities:

  • Serve as regulatory expert for EU product information documents and 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 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, or Pending EU Format) 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
  • Collaborates with Local Affliates and helps communicate 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
  • Responsible for working with suppliers for translation services
Other

  • Be responsible for coordinating and providing Regulatory Labeling Assessments into the quality management system for any changes impacting product labeling as requried
  • Define, develop and execute Global Labeling Operations strategies to maximize regulatory success towards achievement of program objectives across pipeline, including devices
  • Participate in crossfunctional 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

  • Detailed understanding of EU pharmaceutical drug and device development, combination product maintenance, and global regulations and operations pertaining to labeling
  • Ability to manage operational responsibilities across disciplines
  • Works on moderately complex issues where analysis of situations or data requires an indepth evaluation of variable factors. May exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results.
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
  • Selfmotivated, selfstarter 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 ab

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