Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
This role is accountable for ensuring aligned global regulatory strategies for Daiichi Sankyo’s portfolio of drugs across multiple therapeutic areas. This will mainly be achieved through leading, mentoring and developing Global Regulatory Leads (GRLs) from around the world, through direct and indirect line management, establishing clear and consistent processes, ways of working, and communication pathways for all GRLs. Additionally, this role will need to work with key senior stakeholders to oversee the development, communication and execution of long-term global regulatory strategies for assets from clinical development, through registration and lifecycle management. This role will support the achievement of regulatory approvals for a growing pipeline of complex products (incl. ADCs/biologics and cell/gene therapies) in Oncology and Specialty Medicine, whilst bringing significant global regulatory experience and expertise to the regulatory function. This includes ensuring that knowledge, learnings and best practice relating to regulatory strategies are shared and leveraged across the entire portfolio of assets. This role will act as the point of escalation for issues relating to GRL performance, including related conflict management and resolution, or further escalation to relevant leadership or governance committees (incl. GRA-LT). This will also entail coaching and empowering GRLs to coordinate relevant stakeholders and lead the GRT for an asset. As such, the individual in this role should be very experienced in liaising with and influencing Regulatory and cross-functional leaders from across a range of cultural backgrounds and contexts (incl. US, EU, JP, China). This person will sit on key regulatory governance committees including the GRA Leadership Team (GRA-LT) and may serve as deputy for the Global Head of Regulatory Affairs at various company-wide leadership or governance forums (e.g. G-PAD). This person will also chair the Global Regulatory Strategy Committee (GRSC), represents Daiichi Sankyo in forums with major Alliance partners and sit on relevant joint committees as appropriate and necessary, for Daiichi Sankyo’s alliance products.
Responsibilities:
Regulatory Strategy:
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)
Travel Ability: to travel up to 30% business 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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