Head of Global Labelling - Regulatory Affairs

Company: Cpl Healthcare
Location: Boston
Posted on: November 1, 2024

Job Description:

Job Title: Head of Global Labelling - Regulatory Affairs Job Type: Full time permanent position Locations: UK, France, Germany, Ireland, Netherlands, Norway, and the United States of America (Remote) Remuneration: Competitive salary and benefits packageWorking for one of the industry's leading pharmaceutical companies, this is a fantastic opportunity to provide expert regulatory knowledge by providing regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally. In this role, you will lead and oversee global labelling strategy, operations, and compliance, including creation and maintenance of labelling documents; and in doing so bring about enterprise-level change to better meet the needs of a growing business. You will be responsible for implementing and managing processes around labelling globally, overseeing labelling activities worldwide for marketed products, creating and maintaining Company Core Data sheets, and also providing strategic advice in the creation of target labelling for development products. The key job responsibilities:

• Directly oversee and provide strategic and tactical advice for the maintenance and development of CCDS and local labelling deliverables for regulatory filings
• Chair cross-functional Global Labelling Committee and Labelling Working Groups to manage the decision-making process for labelling updates to established products
• Design and implement strategy for the creation of a dedicated Global Labelling function
• Develop, improve, implement and document best-in-class labelling processes, metrics and templates, including influencing stakeholders at all levels
• Lead development of labelling for products in all stages of development including creation of Target Product Labels
• Liaise with other Regulatory Affairs functions to ensure labelling updates are submitted and implemented
• Monitor consistency between local labelling documents and Company Core Data Sheets, and ensure exceptions are documented through standard process
• Provide strategic interpretations of labelling regulations and guidelines in a range of markets including US and EU
• Ensure compliance and performance of labelling processes in accordance with departmental KPIs
• Input into requirements for tools and systems required for the compliant management of labelling documentsThe positions job requirements/qualifications:
  • Minimum of a Bachelor's Degree, preferably in a Scientific or Life Sciences Discipline. A PhD is desirable but not a must.
  • Significant Regulatory Affairs Labelling experience, including direct experience with CCDS, Core Product Information and local labelling in a range of markets including US and EU
  • Demonstrates subject matter expertise in labelling and labelling governance
  • A strategic labeller with expertise in both developing and marketed labels in global regions
  • Experience leading labelling professionals and preferably a global labelling team.
  • Experience with label development including TPP
  • Experience developing, implementing and operating global labelling processes for a pharmaceutical company with worldwide product licencesOther areas of importance:
    • Previous experience in a big pharmaceutical environment, with sound understanding of the complexities in this environment
    • Strong interpersonal skills, ability to forge connections and to influence stakeholders at all levels, in all regions
    • Ability to clearly explain labelling concepts to senior stakeholders and Regulatory Affairs colleagues globally
    • Ability to identify problems and their solutions, as well as driving them to resolution, delegating where necessary to achieve results
    • Ability to learn new technologies, tools and systems quickly - experience with Veeva RIM Submissions and Registrations Vault desiredThis is an excellent opportunity to join a leading business going through a period of growth. This position is a very senior position within the business so will look for a hands on leader who has experience in all aspects of regulatory labelling for both developing and establishing products. To apply for this position please reach out to Please note you must hold the FULL right to work in the locations provided, this role does not provide job sponsorship or relocation. Disclaimer: Due to an influx of applications, not every application can be provided feedback.
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Keywords: Cpl Healthcare, Brookline , Head of Global Labelling - Regulatory Affairs, Other , Boston, Massachusetts