Associate Director, Regulatory Affairs CDx - Daiichi Sankyo

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 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

Responsibilities

• Ensure global regulatory plans support a precision medicine approach e.g. integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies.
• Ensure high quality collaboration global regulatory leads and provides guidance to the regional strategists and collaborates in strategic meetings with health authorities. Represents DS in key interactions with Health Authorities. Ensures compliance of DS programs with regulatory requirements for diagnostics and devices.
• Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products. Provides guidance on planning, writing, review of key dossier documents for submissions globally. Ensure high quality collaboration with Clinical Biomarker and Companion Diagnostics team for development of biomarker, companion diagnostic and other device to optimize access to patients.
• Remains on the forefront of the relevant science, competitive landscape and policy including detailed competitive intelligence and is viewed as an expert in its application to the regulatory process.

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.
• Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred.

Experience Qualifications:

• 4 or More Years of relevant pharmaceutical experience including experience within Regulatory Affairs
• Understanding of scientific content and complexities and good knowledge of diagnostic development, including extensive experience of IDE submissions and approvals
• Extensive experience developing companion diagnostics and devices.
• Experience of drug development and drug regulatory procedures. Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.
• Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives. Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required.

Travel

Ability to travel up to 10% Occasional travel to Health Authority meetings in US and Europe, potentially Japan

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.