Senior Director Global Regulatory Affairs Strategy
4 days ago
Job Summary:
Daiichi Sankyo, Inc. is seeking a Senior Director Global Regulatory Affairs Strategy to lead the development of global regulatory strategies and plans for assigned global projects. The ideal candidate will have 10+ years of experience in the pharmaceutical industry, with 7+ years of direct regulatory affairs experience, including experience in regulatory submissions in Oncology.
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.
Qualifications:
- 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%.
About Daiichi Sankyo, Inc.:
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.
We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools, and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensure that each employee's unique abilities are valued and utilized.
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