Director Strategic Global Labelling
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
OVERVIEW: BioMarin Regulatory Affairs/Global Labelling
BioMarin Global Regulatory Affairs (GRA) is responsible for obtaining approval for new BioMarin products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence. The GRA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.
As part of the Regulatory Affairs organization, the Regulatory Global Labelling (Reg GL) group works on both early development projects and lifecycle changes for mature products. Reg GL is a strategic function, responsible for the development and maintenance of regulatory compliant, competitive, accurate, commercial labelling. Reg GL group manages commercial product labelling End to End; this includes development of early Target Product Labels (TPL), Company Core Data Sheets (CCDS), Patient Labelling, Local Labelling/Prescribing Information for assigned products throughout the product’s lifecycle and implementation of labelling changes including, content on carton/container labels and Instructions for Use. BioMarin’s focus in the rare disease space provides a unique focus on patients. Every patient counts and the Reg GL group supports labelling of our products worldwide including strategic and novel approaches to labelling concepts and timely and compliant implementation to ensure our patients receive these important therapies.
Summary Job Description:
The Director leads the development and maintenance (end to end) of labelling for products worldwide and also serves as EU Labelling Head and in-house expert for EU labelling. The role will be focused on leading labelling teams, talent development, mentoring and resource allocation and share best practices within the organisation. This role may also act as a Global Labelling Lead (GLL) for one or more products based on business needs or act as a Senior Leader with oversight of a GLL as a direct report. The Director of REG-GL provides regulatory labelling leadership to staff and cross functional teams and mentors labelling professionals to achieve regulatory objectives. This role will be part of a highly experienced group of labelling professionals working on diverse labelling projects and products.
This role requires exceptional communication skills and an outstanding ability to proactively navigate change. Advanced aptitudes in decision-making, leadership, strategic thinking, influencing others and cross-functional collaboration are also needed to manage, mentor and lead direct reports and cross functional teams from diverse levels of the organization. The Director will be expected to work on issues where in-depth knowledge and data analysis are required to support and influence leaders on matters of significance for the product and function.
- 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 products
- 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 messages 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.
- Advise 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 implementation 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
This position includes management of at least one direct report and additional staff management of contractors and/or vendors as needed.
DESIRED EXPERIENCE & EDUCATION:
- Knowledge of global labelling guidances, drug development and commercialization 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 ability 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
- Regulatory Affairs experience required
- 3 or more years of line management experience preferred
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties to meet the ongoing needs of the organization.