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Summary
This position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of scientific, regulatory, and business perspectives to ensure compliance with evolving global regulatory requirements and with company objectives. The Head of GRA Global Labeling leads a team of labeling strategists, labeling operations, and compliance specialists located across the US, EU and Japan. They directly oversee and provide strategic and tactical advice for the development and maintenance of the Daiichi Sankyo CCDS, US, EU, Japanese and Asian labeling deliverables for regulatory filings and Health Authority labeling discussions across the product portfolio, for global, regional and local products. They also support labeling activities and provide expert guidance for labels in all markets where Daiichi Sankyo operates. This role is responsible for designing and implementing a process and overseeing country labeling deviations in all markets. This role is accountable for effective and efficient global processes for labeling development and review, and resourcing that incorporates input from cross-functional subject matter experts and senior leadership at Daiichi Sankyo and relevant external collaborators/alliance partners. They will also develop, oversee, and manage implementation of global labeling development and quality review processes, templates, metrics, and systems, while ensuring compliance with FDA, EMA, PMDA and other Health Authority requirements. This role will also be the single point of accountability for all Daiichi Sankyo labeling activities, including representing the function during internal and external audits and inspections. This position represents the function globally and interacts with cross-functional Senior Leadership to resolve complex issues, including leading and contributing to cross-functional initiatives / providing expertise in global labeling best practices.
Responsibilities
- Establish, direct, and supervise the GRA Labeling organization inclusive of regional Labeling Strategy groups and Labeling Operations Compliance across the development product portfolio. Oversee the processes and resourcing for the creation and maintenance of product labeling in the US, EU, Japan and Asian markets (USPI, USPL, USMG, US cartons and container labels, annotated labeling, SPL, EU SmPC, EU PL, EU Annexes QRDs, JPI, JP Medication Guide / Interview Form, and relevant PIs and supporting documents in Asian markets) as well as the CCDS/CCPL. Oversee the process for the review and approval of country labeling deviations from the CCDS. Ensure the GRA Labeling team prepares timely, high quality labeling documents in accordance with applicable regulations and the company position, and in close collaboration with cross-functional global and regional stakeholders, to support regulatory filings and labeling discussions with Health Authorities. Create and mentor a team that interprets complex scientific issues in relation to evolving regulatory requirements, and leverages global labeling expertise to partner with, facilitate discussions with and influence key internal and external stakeholders for issue resolution and solutions. Support product launch activities by partnering closely with Supply Chain Technical Operations teams and Global Regulatory Leads to release high quality labeling components in support of company timelines.
- Accountable for establishing and maintaining processes for ensuring global labeling compliance based on internal and external standards. Establish, manage, and oversee development and maintenance of global labeling processes, metrics, and templates for the CCDS, US, and EU, Japan and Asia. Develop and manage Global Labeling Governance processes and forums, a. And develop efficient processes and adequate resourcing to respond to labeling-related questions during Health Authority inspections and partner PV audits. Review and ensure compliance with PV Agreements and the regulatory labeling portion of contracts with partner companies. Develop and manage shared labeling processes with partner companies.
- Develop and maintain labeling quality management processes and systems. Drive direction of Establish and operationalize best practices through the establishment mentoring of a Labeling Operations and Compliance team. Oversee and provide strategic guidance for the development, implementation, and management of Labeling systems, tools, metrics, and digital technologies to support global labeling compliance. This includes implementation, optimization and management of the labeling Electronic Document Management System (EDMS) and the labeling milestone tracking system along with associated processes for content and change control management. Explore opportunities to leverage emerging digital tools and technologies to support and enhance labeling activities, to drive continuous improvement in efficiency and effectiveness..
- Oversee and/or participate in complex projects providing strategic and operational direction and execution of cross-product and cross-functional projects and teams. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success. Builds cross-functional, cross-regional relationships to maximize efficiency, sustainability and the achievement of business objectives. Navigate complex interpersonal conflicts, influence key senior stakeholders, and act as a point of escalation for cross-functional labeling disagreements. Proactively manage key interdepartmental relationships (including global and regional leaders from Supply Chain, Clinical Safety Pharmacovigilance, Commercial, Medical Affairs and Legal) to ensure accurate and high-quality labeling deliverables and timely management of safety signals into prescribing information. Work directly with Partner companies to reach agreement and implement shared labeling activities.
- People Management: Recruit, onboard, mentor, develop, retain, and manage direct and indirect reports and/or matrix teams. Directly lead a team of >30 FTEs and contractors across regions including the USA, EU and Japan, with indirect responsibility for supporting labeling activities in China. Enable communication, collaboration and alignment within and across functions, with an awareness and understanding of intercultural norms and ways of working. Manage vendors/consultants to oversee alignment with company processes and requirements. Proactively plan for resource management and allocation for current and upcoming products. Manage competing priorities and use leadership and influencing skills to drive and deliver projects in a matrix environment.
Qualifications:
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Bachelor's Degree preferably in a scientific discipline required
- Master's Degree preferably in a scientific discipline preferred
- PharmD preferably in a scientific discipline preferred
- PhD preferably in a scientific discipline preferred Experience Qualifications
- 10 or More Years pharmaceutical industry experience required
- 10 or More Years regulatory affairs experience, including direct experience with CCDS, US and and EU label development, and a strong understanding of labeling documents and requirements in Japan experience required
- 7 or More Years Experience with country labeling (outside the US, EU and Japan), including parallel filings required
- 4 or More Years leading a global labeling function required
Travel Ability to travel up to 20% May require occasional global travel
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.