Senior Director Global Regulatory Affairs Strategy
3 weeks 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.
-
Global Regulatory Affairs Strategy Director
3 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeGlobal Regulatory Affairs Strategy DirectorDaiichi Sankyo Group is a leading pharmaceutical company dedicated to creating and supplying innovative therapies to improve standards of care and address unmet medical needs globally. As a Global Regulatory Affairs Strategy Director, you will play a crucial role in shaping the company's regulatory strategy for...
-
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob OverviewThis is a senior leadership position responsible for providing strategic direction and oversight for global regulatory submissions in Oncology. The successful candidate will ensure alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives.Key ResponsibilitiesThis position will...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeGlobal Regulatory Affairs Strategy LeadDaiichi Sankyo Group is dedicated to creating and supplying innovative pharmaceutical therapies to improve standards of care and address diverse, unmet medical needs globally. As a key member of our team, you will be responsible for providing oversight and formulation of strategy for global regulatory submissions in...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob SummaryThis 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...
-
Global Regulatory Affairs Strategy Director
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeRole SummaryThis position is responsible for providing strategic oversight and formulation of regulatory strategies for global submissions in Oncology across the US, EU, Japan, China, and other regions. The role ensures alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives.Key...
-
Regulatory Affairs Director
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeRegulatory Affairs DirectorDaiichi Sankyo, Inc. is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing US regulatory strategies for assigned projects. Your expertise in FDA regulations and guidelines will be essential in ensuring timely and...
-
Regulatory Affairs Director
4 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob SummaryThis role offers the opportunity to contribute to the mission of Daiichi Sankyo in leveraging innovative science to create meaningful treatments for patients with cancer. The Director of Regulatory Affairs will work on one of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA. This role will create and implement...
-
Regulatory Affairs Director
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Summary:Daiichi Sankyo, Inc. is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Liaise with FDA to ensure timely and quality submissionsPrepare and publish regulatory documents...
-
Regulatory Affairs Director
3 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob SummaryThis role offers the opportunity to contribute to the mission of Daiichi Sankyo in leveraging innovative science and creating meaningful treatments for patients with cancer. The successful candidate will develop and implement effective regulatory strategies to deliver on efficient and robust development plans. They will direct, coordinate and...
-
Global Regulatory Affairs Labeling Expert
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob SummaryWe are seeking a highly skilled Global Regulatory Affairs Labeling Expert to join our team at Daiichi Sankyo, Inc. This role will be responsible for providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products.Key...
-
Director of State Government Affairs
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJob SummaryWe are seeking a highly skilled Director of State Government Affairs to join our team at Daiichi Sankyo. This role will be responsible for leading our engagement across the United States to ensure patient access to our current portfolio and robust pipeline of medicines.Key ResponsibilitiesDevelop and lead Daiichi Sankyo's legislative and...
-
Associate Director, Global Business Strategy
1 month ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Global Business StrategyAbout Daiichi Sankyo, Inc.Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to improving healthcare outcomes through innovative therapies. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to addressing unmet medical needs and improving...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeAbout the RoleWe are seeking a highly skilled and experienced professional to lead our Companion Diagnostics efforts in support of our Early and Late-Stage Development Portfolio.As a key member of our team, you will play a critical role in guiding the strategy and implementation of Companion Diagnostics, working closely with our Global Program Teams,...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Global Strategy and OperationsAt Daiichi Sankyo, Inc., we are committed to creating innovative pharmaceutical therapies to improve standards of care and address unmet medical needs globally. We are seeking an experienced Associate Director, Global Strategy and Operations to join our team.Key Responsibilities:Support the Head,...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob SummaryThe primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The individual will play a key role in making Precision Medicine a reality for patients who are likely to benefit from our...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob SummaryThis role is responsible for supporting the strategic leadership of quality assurance initiatives within the organization. The incumbent will collaborate with the head of global QA strategy and operations to ensure the successful execution of QA projects and initiatives. Key responsibilities include drafting global communications, ensuring the...
-
Basking Ridge, New Jersey, United States College of Charleston Full timeGlobal Oncology Medical Affairs FellowshipThis 2-year Fellowship position is a joint effort between the Rutgers Institute for Pharmaceutical Industry Fellowships (RPIF) and Daiichi Sankyo, Inc.The program emphasis is in Global Oncology Medical Affairs, providing a unique opportunity to transform the scientific evidence of the broad and innovative Daiichi...
-
Associate Director, Companion Diagnostics Lead
4 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob SummaryThe Associate Director, Companion Diagnostics Lead will play a key role in guiding the strategy and leading the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio.This position will contribute to CDx project teams for the diagnostic, under the direction of the...
-
Senior Medical Director, US Oncology
3 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeTransforming Oncology CareAt Daiichi Sankyo, Inc., we are dedicated to creating innovative pharmaceutical therapies that improve standards of care and address unmet medical needs globally. As a key member of our Executive Leadership team, the Vice President, Medical Affairs will play a pivotal role in shaping the strategic direction and long-term vision for...
-
Director of Companion Diagnostics Innovation
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJob SummaryAs a seasoned professional in the field of companion diagnostics, you will play a pivotal role in guiding the strategy and leading the implementation of CDx projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. Your expertise will be instrumental in making Precision Medicine a reality for patients who can benefit from our...