Science & Technology

Director Strategic Global Labelling

Not Specified

We’re looking for a candidate to this position in an exciting company.

  • Provide regulatory strategic guidance and oversight of global labelling end to end activities for assigned product
  • Provide strategic input on interpretation and implementation of labelling regulations and guidelines in the EU and for International markets in consultation with Reg International
  • Manage labelling staff and contactors operating out of the London Office
  • Create and maintain regulatory compliant, competitive and up to date CCDS for assigned product s
  • Present proposed CCDS content and changes to Executive Labelling Committee for labelling decision making and management of high-quality documentation supporting changes to the CCDS
  • Manage the Product Labelling Team (PLT), a cross-functional, global team formed to ensure appropriate subject matter expertise is provided during label development (CCDS and Local Labels) .
  • Develop labelling negotiations strategic plan for the assigned product to support health-authority (HA) reviews and label negotiations (in writing, phone or in person) as appropriate
  • Generate labelling -related responses to Health Authority queries. Review of summary documents such as clinical overviews to ensure the labelling key message s are consistent throughout the marketing application
  • Prepare labelling documents (including annotations if required) to support regional regulatory filings, including liaising with GRT regional representatives and relevant SMEs .
  • Advis e teams on the degree of data and evidence required to support labelling claims in close collaboration with the appropriate stakeholders , expertly guiding label teams, executives and HAs
  • Develop content in accordance with local regulatory requirements to be presented on Instructions For Use (IFUs), carton and container labels
  • Manage the review and approval process within the product labelling teams, including outlining the label history and documentation of team decisions. Provide and maintain background documents outlining the purpose and justifications for labelling changes. This includes local labelling content and global labelling content (CCDS)
  • Manage high quality labelling documents in accordance with QRD templates/EU requirements, label annotations, USPI SPL files , and other regional labelling requirements as applicable
  • Prepare international labelling in accordance with local requirements and ensure translations are properly executed (via translation vendor)
  • Oversight of staff supporting final labelling artworks for submission and/or implement ation into production. Manage the approval all change requests for revised labelling for assigned projects/products. Provide Supply Chain and QA guidance on labelling implementation requirements. Support first launch into new markets .
  • Ensure compliance with CCDS labelling concepts across local labelling worldwide and provide guidance to ensure activities are appropriately captured in Reg GL tracking system
  • Liaise with Packaging Ops (Tech Ops) to obtain mock ups /artwork and specimens for regional regulatory submissions
  • Support or lead special Labelling or Regulatory related initiatives as needed for continued process improvements or for new regulatory requirements
  • Knowledge of g lobal l abelling g uidances , d rug d evelopment and c ommercialization of prescription medicines including expertise at proactively recognizing and communicating implications of regulatory actions; assessing trends in the regulatory environment and their implications for regulatory strategy and product labels
  • Proven understanding of the dynamics and purpose of the CCDS and the implications of the CCDS
  • Proven ability to understand regulatory implications of product strategy related to labelling development, assessment and management
  • Proven a bility to author new labels from scratch; accurately interpreting and synthesizing scientific / technical content into standard, compliance label content and formats
  • Demonstrated ability to develop strong and positive working relationships across diverse teams and within a global environment
  • Ability to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making
  • Comprehensive knowledge of labelling systems and processes
  • Proven ability to develop and manage a highly competent and technically skilled team
  • Experience in managing high to medium complex projects
  • Excellent verbal and written communication skills
  • Keen attention to detail and accuracy
  • Ability to assimilate clinical and scientific information and present it in a concise manner , including having a comprehensive understanding of expected study/program outcomes, endpoints, data and the related regulatory expectations
  • Ability to think creatively and good excellent problem-solving skills
  • Experienced people leader
  • Degree in health or life sciences, or similar. Masters/Bachelors or higher with relevant experience
  • 7 + year experience with PhD; 10+ years with Masters, 12+ with bachelor’s degrees
  • 3 or more years of line management experience preferred

Employment Type Permanent

Advertiser Type Agency