Senior Director Global Regulatory Affairs Strategy
1 month ago
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:
This position (GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other regions. This position ensures alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives. This position serves as the primary contact for interactions with cross-functional team members and leads complex discussions at the project team level as well as at governance meetings. This position mentors/instructs and provides guidance to internal and external direct/indirect reports. This position also interacts with other therapeutic area leaders and joint Alliance partners.
Responsibilities:
- Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects. Gain endorsement from the Global Project Team (GPT) for these plans, ensuring appropriateness throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo governance processes, and on Joint Alliances. Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area strategy, corporate goals, and regional regulatory requirements/precedence.
- Represent Daiichi Sankyo's regulatory group in internal and external development project meetings. Provide guidance to peers and cross-functional team members regarding strategic regulatory issues. Develop timeline and strategic input with feedback from the regional strategists in terms of Health Authority meetings globally. Provide leadership and set direction, acting as a key decision-maker and/or arbitrator on global projects.
- Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within the company as needed. In collaboration with Regulatory Intelligence and Policy team members, review and interpret regulatory guidelines, regulatory precedence and competitive landscape with respect to impact on development programs. Ability to serve and participate on internal and external panels related to Health Authority initiatives. Review of clinical study protocols, health authority dossiers and briefing books.
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
- 10 or More Years Experience in the pharmaceutical industry
- 7 or More Years with direct regulatory affairs experience, including experience in regulatory submissions in Oncology
- Managerial experience
- Experience with ex-US regulatory authorities
- 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.
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