Senior Director Global Regulatory Affairs Strategy
1 day ago
This position is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other regions.
The successful candidate will ensure alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives.
This role 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.
The position mentors/instructs and provides guidance to internal and external direct/indirect reports.
This role also interacts with other therapeutic area leaders and joint Alliance partners.
Key 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, 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.
- Bachelor's Degree required.
- Advanced degree (e.g., Masters, Pharm.D., Ph.D.) in a scientific discipline preferred.
- 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%.
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