Senior Manager EU Brand Labeling 100%

Basel, Switzerland

Posted: 25-Sep-2017

Ref#: TPIG-0065


Business Purpose

Teva Pharmaceuticals International GmbH in Switzerland is looking per January 1st for a Senior Manager EU Brand Labeling responsible for driving and optimizing the strategy for the development, revision, and management of European labeling for an assigned portfolio of brand/specialty products. As a senior member of the team and subject matter expert you will train and mentor less experienced Brand Labeling professionals and deputize the Head of the group as needed. 

Main Responsibilities
  • Lead the creation and maintenance of regulatory compliant, competitive, and up-to-date EU labeling documents (SmPC, PIL, Labeling) for an assigned portfolio of brand/specialty products 
  • Provide strategic and operational regulatory labeling guidance
  • Ensure compliance with internal labeling policies/processes and assure conformity with EU labeling guidelines/regulations
  • Manage the internal labeling review and approval processes
  • Lead and/ or contribute to process improvement initiatives
  • Organize and lead cross- functional Product Working Groups (PWGs) to reach consensus on EU labelling matters and to prepare high quality EU labeling documents and documents to support labeling changes (e.g. Expert Statements)
  • Ensure that key regional/market RA input is sought and incorporated into EU labeling strategy
  • Guide and support the local/market RA teams for local labelling-related Health Authority (HA) negotiations to ensure consistency and compliance with the overall EU and global strategy for the brand
  • Drive and coordinate responses to Health Authority queries related to related to EU common labeling, and participate in internal audits and Health Authority inspections as required
  • Coach and mentor newcomers as well as less experienced EU Brand Labeling Managers
  • Deputize for the Head of EU Brand Labeling as required
Requirements
  • Master’s Degree in life science (Pharmaceutical, Regulatory Affairs), preferably  with a PhD
  • 6-8 years' experience within the Pharma industry
  • Minimum of 5 years' experience within Labeling in development projects and/or maintenance products at EU or global level
  • Ability to think strategically, assess and evaluate risks and formulate strategies to manage them
  • Solid knowledge of EU labeling guidelines and regulations
  • Expert proficiency in managing labeling processes and texts at EU or global level
  • Excellent written and verbal communication skills
  • Keen attention to detail, accurate, process minded and quality driven 
  • Excellent project management, organizational and strong analytical skills
  • Experience in leading cross-functional teams
  • Proficiency in English Regulatory Affairs technical language, additional language skills in German and French is an asset
Our offer

  • Working for one of the top 10 global pharmaceutical companies in an international environment
  • Innovative position driving the strategy for the development and management of European labeling for an assigned portfolio of brand/specialty products of high priority
  • Challenging and responsible position in a motivated team 
  • Market competitive remuneration package


Information for Recruitment Agencies:
Mepha Schweiz AG and Teva Pharmaceuticals International GmbH as well as all related entities (in the following Mepha/Teva) do not accept any candidate submission from unsolicited third parties. Candidates presented by unsolicited third parties (such as recruitment agencies, head hunters etc.), will not be entered into the recruitment process and will not be considered further. Further on, no contractual relationship will result out of such a submission between Mepha/Teva and a third party. Mepha/Teva is not obligated nor willing to pay any fee to third parties submitting candidates in this manner.

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About Serendi

Serendi is a recruitment service provider with its headquarters in Switzerland. Our clients are large Swiss or international companies.

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