Director Global Regulatory Affairs NJ

4 weeks ago

new jersey, United States Daiichi Sankyo, Inc. Full time

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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.   

Summary:

Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. Conduct completeness, scientific accuracy, and ease of review of the submissions. Provides guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback from the regional strategists in terms of HA meetings globally. Responsible for representing GRA in the GPT (Global Project Team) as well representing the project team in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre-clinical groups, Regulatory CM&C and other appropriate group within the company as needed.
Responsibilities:

  • Manages, directs, and drives the strategy for all Regulatory activities associated with the registration and support of new and approved drug products.
  • Seeks and incorporate regional and functional RA strategy into a global strategy.
  • Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.
  • Serve as a leader of the GRT (Global Regulatory Team)
  • The primary point of contact with Alliance Partners Joint-RA teams and Joint-GPT as applicable.
  • Supervises the identification and compilation of required documentation for submission. Prioritizes workload as necessary.
  • Keeps current with latest Health Authority guidelines and provides Regulatory advice to members within Regulatory, and various associated departments within the Company. Also communicates with outside consultants (i.e. CRO’s) as needed.

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 proven experience in a regional regulatory lead role
  • 7 or More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs
  • Knowledge of IND, NDA/BLA submission experience
  • Experience with regulatory submission strategy globally will be preferred but not required.
  • Experience in providing regulatory strategic input into the Oncology drug development preferred.
  • Ability to interpret and understand US regulations governing the pharmaceutical industry; general global knowledge of regulations, such as ICH is desirable.
  • Experience with CTD/eCTD preparations preferred.

Travel:

Ability to travel up to 30% In-house office position that may require occasional travel (global).

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.

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