Manager, Regulatory Affairs - RPM - Daiichi Sankyo Inc.
Basking Ridge, NJ
About the Job
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. 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
The Manager, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and activities to achieve regulatory milestones and deliverables successfully and in a timely manner. The manager, RPM contributes to the RPM group by sharing best practice and escalating process and operational issues in a timely manner and continuous RPM process improvement with focus on quality, reliability, consistency and efficiency.
Responsibilities
+ Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.).
+ Develop less complex Module 1 regulatory documents (e.g. cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions.
+ Support FDA meeting preparation including preparation of briefing document, meeting request, response to FDA preliminary comments and logistics.
+ Support FDA meeting preparation including preparation of briefing document, meeting request, response to FDA preliminary comments and logistics.
+ Support GRL with scheduling regulatory meetings, preparing agenda and tracking action items
+ Responsible for maintaining global health authority query (HAQ) tracker and archiving regulatory correspondences.
+ Support DSUR/PBRER preparation by attending Kick-off Meeting, coordinating and assisting in developing regulatory sections.
+ Schedule RRT meeting, creates response templates and coordinates processes for authoring and review of response as appropriate.
+ Provide support or coordinate other regulatory activities per direction from GRL and regulatory strategists.
+ Share RPM best practices and contributed to RPM process improvement
+ Keep current with regulatory and scientific regulations, guidelines and initiatives
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 Preferably in a scientific discipline required
+ Advanced degree (e.g., Masters, Pharm.D., Ph.D.) preferred
Experience Qualifications
+ 4 or More Years Relevant pharmaceutical experience (education and/or industry)
+ 1 or More Years Industry experience (within regulatory is preferred)
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.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. 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 ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.
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. 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
The Manager, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and activities to achieve regulatory milestones and deliverables successfully and in a timely manner. The manager, RPM contributes to the RPM group by sharing best practice and escalating process and operational issues in a timely manner and continuous RPM process improvement with focus on quality, reliability, consistency and efficiency.
Responsibilities
+ Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.).
+ Develop less complex Module 1 regulatory documents (e.g. cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions.
+ Support FDA meeting preparation including preparation of briefing document, meeting request, response to FDA preliminary comments and logistics.
+ Support FDA meeting preparation including preparation of briefing document, meeting request, response to FDA preliminary comments and logistics.
+ Support GRL with scheduling regulatory meetings, preparing agenda and tracking action items
+ Responsible for maintaining global health authority query (HAQ) tracker and archiving regulatory correspondences.
+ Support DSUR/PBRER preparation by attending Kick-off Meeting, coordinating and assisting in developing regulatory sections.
+ Schedule RRT meeting, creates response templates and coordinates processes for authoring and review of response as appropriate.
+ Provide support or coordinate other regulatory activities per direction from GRL and regulatory strategists.
+ Share RPM best practices and contributed to RPM process improvement
+ Keep current with regulatory and scientific regulations, guidelines and initiatives
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 Preferably in a scientific discipline required
+ Advanced degree (e.g., Masters, Pharm.D., Ph.D.) preferred
Experience Qualifications
+ 4 or More Years Relevant pharmaceutical experience (education and/or industry)
+ 1 or More Years Industry experience (within regulatory is preferred)
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.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. 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 ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.
Source : Daiichi Sankyo Inc.