Director, US Regulatory Affairs Strategy (Oncology)

Job Summary: This role offers the opportunity to substantially contribute to the mission in leveraging our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer.

This role will work on one of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the company’s growth, thereby accomplishing corporate goals. Responsibilities:

· Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings.

· Serve as the primary contact with FDA and liaise, negotiate and orchestrate meetings and teleconferences with FDA

· Lead and prepare FDA submissions, including but not limited to briefing documents, breakthrough therapy designation requests, orphan drug applications.

· Participate in global project team meetings (development and/or marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities. Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.

· May serve as the single regulatory representative on study teams

· Review and interpret regulatory guidelines.

Continuing Education: Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: BS degree in chemistry, biology or other related scientific discipline required. Masters, PhD or PharmD highly desired. 10+ years in the pharmaceutical industry. 8+ years in regulatory affairs.

Experience in providing regulatory strategic input into the drug development process with thorough knowledge of the IND and NDA/BLA processes.

Ability to interpret and understand US regulations governing the pharmaceutical industry; general global knowledge of regulations, such as ICH is desirable. (s)NDA/BLA filing to FDA considered a plus.

Competencies

· Excellent oral and written communication skills, strong interpersonal skills; ability to work in a team environment; can work in high stress and deadline driven environment. Energetic, self-motivated and multi-task oriented person.

· Proactive, disciplined, organized and detail oriented. Attention to detail is required.

· Demonstrates ability to think logically and objectively when identifying significant problems and opportunities