Daiichi Sankyo, Inc.
Location
New Jersey | United States
Job description
Join a Legacy of Innovation 110 Years and Counting!
Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.
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.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 requiredTravel 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.
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