Sr. Director Global Regulatory Lead in Basking Ridge at Daiichi Sankyo

Date Posted: 12/9/2022

Job Snapshot

Job Description

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. 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

This role is responsible for leading multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategies and plans for global projects and gain Global Project Team (GPT) endorsement of plans as appropriate throughout the lifecycle and across indications for the given product(s).  The development of global regulatory strategies and plan will involve assessing and articulating regional interdependencies, program regulatory risks and opportunities and various global opportunities taking into consideration both the therapeutic area strategy, corporate goals and regional regulatory requirements/precedence. This position pro-actively reviews and interprets regulatory guidelines, regulatory precedence and competitive landscape with respect to impact development programs. 


This position serves as the regulatory point of contact with the GPT. This position provides oversight of regulatory activities, leads or directs complex global projects and focuses on big picture strategic decisions and problem solving.  This position provides leadership and sets direction, acting as a key decision-maker and/or arbitrator on global projects. This position motivates self and others to complete projects on time and can make day-to-day submission decisions without prior approval. This position refers decisions that may be in conflict with regulatory norms to a higher authority



Responsibilities
  • Registration Strategy: Regulatory Lead accountable for global RA strategy and planning. Provides input/oversight of the formulation of registration strategies for global projects.   Provides oversight to ensure US and/or global registration strategies are outlined in RA strategic plans. Provides oversight to ensure registration strategies adhere to therapeutic area direction and corporate objectives. This position is accountable to Global Head of RA, and Global Regulatory Strategy Committee (G-RSC) for delivering global regulatory strategies. For Alliance Products this position is also accountable to Alliance Global Regulatory Team Lead for delivering Alliance coordinated and aligned global regulatory strategies
  • Team Interactions: Provides global representation on project teams;  Acts as the primary point of contact between GRA and a GPT, GRSC, GROC and GRA LT.  Responsible to communicate GPT/governance decisions and activities to the GRT  RA expert in cross-functional initiatives. Interacts with senior managers within Daiichi Sankyo on scientific and regulatory issues.  Primary point of contact with Alliance Partners Joint RA teams and Joint GPTs if applicable
  • Leads GRT in planning and strategizing for Health Authority interactions  and submissions around the world (e.g. Briefing Documents, Agency Meetings), and collaborates with the Regional Strategists and Regulatory Sub-functions (e.g. Medical Writing) to execute these plans.  Seeks and incorporates regional and functional RA strategy into global strategy
  • Pro-actively reviews and interprets regulatory guidelines, regulatory precedence and competitive landscape with respect to impact development programs

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 required
  • Advanced degree (e.g., Masters, Pharm.D., Ph.D.) in a scientific discipline preferred
Experience Qualifications
  • 7 or More Years' experience in the pharmaceutical industry required with direct regulatory affairs experience
  • Experience in providing regulatory strategic input into the drug development process 
  • Experience with CTD/eCTD preparations and submissions

Travel
Ability to travel up to 20% 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.