Sr. Manager, Regulatory Affairs Strategy

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers.

Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission.

Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust.

By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other.

Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients.

Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients.

It’s our work, our passion, and our legacy.

We invite you to join us.

Hybrid

Employee Value Proposition:

Join our dynamic and expanding mid-size company as a Sr.

Manager, Regulatory Affairs Strategy.

In this role, you will support submissions for various developmental, life cycle, and post-approval projects in the US, EU, Canada, and beyond.

You will work closely with colleagues from the US, EU, and Japan, gaining valuable global experience while contributing to cancer patients' lives.

Our company's size allows for direct interaction with various functions within our organization, providing a comprehensive, hands-on experience.

You will have the opportunity to enhance and showcase your skills in an inclusive environment that encourages continuous learning and professional growth.

Position Summary:

Under the direction of regulatory affairs management, the incumbent independently prepares and directs global regulatory affairs activities and provides regulatory guidance during drug development, approval and post approval processes and commercialization, in coordination with both the internal and external consultants and contractors in the oncology therapeutic area.

The incumbent conducts regulatory activities to ensure high quality, regulatory integrity and completeness of all projects, supporting IND, CTA, NDA, MAA submissions.

Performance Objectives:


* Manage and support the preparation, review, and submission of all components of regulatory submissions as assigned, including INDs and amendments, CTAs, marketing applications (NDA/MAA), annual reports, safety reports, etc.


* Support planning and executing regulatory submissions requiring cross-functional collaboration and alignment.


* Prepare, submit and track submissions


* Establish, manage, and maintain a knowledge base of current and emerging clinical regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues.


* Assure compliance with regulatory standards and guidance documents  
...