Job Summary

The Global Regulatory Lead (GRL) is responsible for leading and developing global regulatory strategy for assigned development projects. The GRL represents Daiichi Sankyo's regulatory group in internal and external development project meetings, provides guidance to peers and cross-functional team members regarding strategic regulatory issues, and develops overall regulatory strategy with input from respective regional strategists for global Health Authority interactions. The GRL is responsible for representing Global Regulatory Affairs on the Global Project Team (GPT), as well as in early- and late-stage governance meetings. The GRL interfaces with clinical and non-clinical groups, Regulatory CM&C, Biostatistics, Companion Diagnostics, Precision Medicine, and other appropriate functions within the company.

Job Description

Responsibilities

• Manages, directs, and drives the strategy for all regulatory activities associated with the registration and support of new and approved drug products.
• Responsible for ensuring aligned global regulatory strategy is endorsed by the Global Project Team and governance bodies.
• Serves as a leader of the Global Regulatory Team (GRT) and is responsible for strategic integration of regional strategies, including an understanding of CMC, supply chain and commercialization aspects to support Health Authority requirements. This includes review of key regulatory documents, e.g., protocols, briefing books, and health authority submission documents.
• Serves as the primary point of contact with Alliance Partners Joint-regulatory teams and Joint-GPT.
• Keeps current with latest Health Authority guidelines and provides regulatory advice to members within Regulatory, and other departments within the Company.
• Communicates with outside consultants (i.e. CROs, external partners) as needed.

Qualifications

Education Qualifications (from an accredited college or university)

• Bachelor's Degree preferably in a scientific discipline required
• Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred

Experience Qualifications:

• Broad and deep scientific and regulatory expertise in early- and late-stage development across modalities and therapeutic areas with focus on oncology
• Drug Discovery and Development knowledge across the R&D continuum
• 7 or more years of relevant pharmaceutical experience including 5 years of experience in a Strategy role within Regulatory Affairs
• Hands on NDA/BLA submission experience in a major geographical region, including the US
• Demonstrated experience in global Health Authority negotiations
• Manages complexity of regulatory strategy across regions and has the knowledge to provide regulatory guidance based on understanding of global regulations
• Communicates and collaborates effectively and deals well with ambiguity
• Working knowledge of CMC and Companion Diagnostics

Travel Requirements

Ability to travel up to 20% of the time.