Director, Regulatory Affairs

Location
Basking Ridge, NJ, United States
Posted
Oct 29, 2020
Ref
10530BR
Hotbed
Pharm Country
Required Education
Masters Degree/MBA
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:

This role offers the opportunity to substantially contribute to the mission of Daiichi Sankyo Cancer Enterprise 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 Antibody-Drug Conjugate (ADC) assets by effectively liaising, negotiating and partnering with FDA, EMA, PMDA and other health authorities around the world. 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 regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); 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:
Serve as a Global Regulatory Lead:
• Liaise, negotiate and orchestrate regulatory interactions with health authorities around the world.
• Lead submission teams in the preparation and assembly of regulatory submissions (e.g. BLAs, INDs, CTAs, Annual Reports, Safety Updates, Quarterly Reports, etc.)
• Develop global regulatory strategies in conjunction with the global regulatory team. .

Provide regulatory leadership, support and guidance and manage day-to-day regulatory activities. Responsible for ensuring strategies are aligned to global product team goals and objectives.
• Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.
• Review and interpret regulatory guidelines.
• Review RA and related documents for approval.

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. 5+ years in global regulatory affairs, NDA, sNDA, BLA filing to FDA considered a plus.
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
Director, Regulatory Affairs

City
Basking Ridge

Functional Area
Regulatory Affairs Oncology

State
New Jersey