Senior Manager - EU Brand Labeling

We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world.
We estimate that Teva provides medicines to 200 million patients around the world every day.
We develop, produce and market affordable generic medicines, as well as innovative and specialty pharmaceuticals and over-the-counter consumer healthcare products, along with supplying active pharmaceutical ingredients to nearly 1,000 customers in over 100 countries. We work tirelessly to transform science, research and patient insights into effective treatments for disorders of the central nervous system, pain and respiratory conditions.
We would like to invite applications for the role of Senior Manager - EU Brand Labeling
About the role:
The Senior Manager, EU Brand Labeling drives and optimizes the strategy for the development, revision and management of European labelling for an assigned portfolio brand/specialty products of high priority or with a certain degree of complexity from a labeling perspective.
Key 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 (high priority or complex brands).
• 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).
• Manage the internal labeling review and approval processes in accordance with the company standards. Lead the presentations to the Labeling Review Board and all labelling related follow-up activities related to the conclusions of Labeling Review Board meetings.
• Drive and coordinate responses to Health Authority queries related to EU common labelling. Participate in HA labeling negotiation meetings as required.
• Guide and support the local/Market RA teams for local labeling-related Health Authority (HA) negotiations to ensure consistency and compliance with the overall EU and global strategy for the brand.
• Ensure appropriate tracking of labeling documents via defined procedures and optimize use of document management systems.
• Ensure that key regional/market RA input is sought and incorporated into the EU labeling strategy
• Supervise management of the translations of labeling texts in close collaboration with external service suppliers and/or local affiliates within the framework of original MAA or variations.
• Provide regular input to artwork management regarding Branded products. Manage the artwork request and review process for regulatory submission purposes ( mock-ups) as defined by the SOPs and work instructions for labeling processes.
• Supervise management of PIL user testing requests.
• Oversee and ensure adequate follow-up on EU market implementation of common texts, and in particular changes to CCSI (Company Core Safety Information).
• Provide senior level labelling expertise for the creation of the initial company core data sheet (CDS), ensuring that EU input is adequately integrated. Lead CDS creation projects as required.
• Review and assess competitor labeling for marketed products in the same therapeutic area/pharmacological class to support labeling development and update projects.
• Lead and/or contribute to EU or global labelling continuous improvement initiatives. Contribute as a subject matter expert to regulatory or company initiatives with a labeling impact.
• Review and comment on emerging labeling related internal and external guidelines and regulations.
• Coach and mentor newcomers / less experienced EU Brand Labeling Managers.
• Lead and/or contribute to the development and maintenance of SOPs and work instructions impacting labeling processes.
• Ensure compliance with regulatory requirements and internal policies and processes. Contribute to/participate in internal audits and Health Authority inspections as required.
• Deputize for the Head of EU Brand Labeling as required.

Qualification and Experience

• University degree in life sciences or pharmacy (BSc, MSc, PharmD, PhD) preferred.
• An extensive pharmaceutical industry experience with "hands on" labeling experience including content development and maintenance of labeling texts. Broader regulatory experience is considered as a prerequisite.
• Solid knowledge of EU labeling guidelines and regulations.
• Demonstrated expert proficiency in managing labeling processes and texts in accordance with regional and global regulatory requirements.
• Has a good understanding of the clinical development process and the potential implications of clinical development objectives in the context of labeling.
• Led cross-functional teams or has a comparable experience in other similar team settings in a global or regional role. Demonstrated ability to influence without authority and navigate confidently in a complex matrix organization and across diverse cultures.

Skills and Competencies:

• Possesses team spirit, the ability to prioritize adequately and to adhere to strict and demanding timelines.
• Keen attention to detail, accurate, process minded and quality driven.
• Excellent written and verbal communication skills with the ability to meet regulatory requirements and standards while maintaining effective relationships.
• Ability to assimilate clinical and scientific information and present it in a concise manner.

Strong analytical, project management and organizational skills with the competency to coordinate effectively large and diverse projects simultaneously.