Senior Director, Regulatory Affairs - Companion Diagnostics

Location
Basking Ridge, NJ, United States
Posted
Jun 10, 2021
Ref
10703BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
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. 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.

Job Summary:

Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.

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 diagnostics and other devise 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/Experience:
  • Solid scientific background, Ph.D., M.D., PharmD, MS, or BS
  • Significant experience in regulatory affairs and diagnostic related development (e.g. > 8-10 years)
  • 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

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.

Job Title
Senior Director, Regulatory Affairs - Companion Diagnostics

City
Basking Ridge

Functional Area
Regulatory Affairs Oncology

State
New Jersey