Director Strategic Global LabellingLocation London, United Kingdom Apply
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 GRA organization, the Regulatory Global Labelling (Reg GL) group is a strategic function, responsible for the development and maintenance of regulatory compliant, competitive, and accurate commercial labelling. The Reg GL group manages commercial product labelling End to End. 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.
Summary Job Description:
The Director leads the development and maintenance (end to end) of labelling for products worldwide and serves as EU Labelling Head and in-house expert for EU labelling. The role will be focused on leading labelling teams, talent development of direct reports, mentoring and developing staff and contributing to best labelling 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. 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 products
- Develop content in accordance with local regulatory requirements to be presented on Instructions for Use (IFUs), carton and container labels and prepare labelling documents (including annotations if required) to support regional regulatory filings
- Provide strategic input on interpretation and implementation of labelling regulations and guidelines in the EU and for International markets in consultation with Regulatory partners
- 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
- Develop labelling negotiations strategic plan and prepare responses to Health Authority queries for assigned products to support health-authority (HA) reviews and label negotiations (in writing, phone or in person) as appropriate
- Advise teams on the degree of data and evidence required to support labelling claims in close collaboration with the appropriate stakeholders
- Manage high quality labelling documents in accordance with QRD templates/EU requirements, label annotations, USPI SPL files, and other regional labelling requirements as applicable
- 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
DESIRED EXPERIENCE & EDUCATION:
- Extensive knowledge of global labelling guidance and regulations, drug development and commercialization of prescription medicines
- Proven understanding of the dynamics and purpose of the CCDS and management of global labelling
- 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
- Experience in managing high to medium complex projects
- Excellent verbal and written communication skills
- Keen attention to detail and accuracy
- Ability to think creatively, navigate ambiguous regulatory environment and 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.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.