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: 

At Taiho Oncology, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. This is an exciting opportunity to work in a diverse, talented, and committed group of people to advance the treatment for oncology patients and experience multiple facets of regulatory affairs in a dynamic, collaborative, and global cross-functional environment.

Position Summary: 

• ​​The incumbent is responsible for supporting Regulatory Affairs activities (nonclinical, clinical and safety) for assigned investigational development products from nonclinical candidate designation through product approval, including regulatory submissions. This individual is responsible for maintaining an in-depth awareness of relevant federal and international regulations and policies to optimize regulatory input to assigned projects and teams.

Performance Objectives:

• Work with Regulatory strategists to implement process and ensure on-time Regulatory routine submissions for assigned programs
• Support Regulatory strategists in coordination of Regulatory Submission teamwork and meetings (e.g., help to maintain resource plans, initiate intranet document workflows for review and approval, help to maintain submission timelines, and initiate document inventories in collaboration with the RA lead and Regulatory Operations Publisher)
• Collect Regulatory information to support QP product specification files
• Coordinate archival of submission information and Regulatory Health Authority
• acknowledgement
• Train on CREDO to maintain and update published documentation in that repository for
• assigned projects
• Provide regulatory project management to support submissions
• Independently prepare routine regulatory submissions
• Review relevant documents from a regulatory perspective
• Other tasks and responsibilities as directed by the Regulatory Affairs team
• Maintain up-to-date knowledge of current regulations for applicable territories

Education/Certification Requirements: 

• Bachelor’s degree in a relevant discipline

Knowledge, Skills, and Abilities:

• Minimum of 2 years of pharmaceutical industry experience
• Knowledge of the drug development process, drug laws, and global regulations and requirements is preferred
• Experience with submitting and managing global clinical trial applications preferred
• Experience supporting development stage programs (Phase 1-3) in oncology highly desirable
• Strong analytical skills, problem solving ability, and presentation skills, or desire to develop these skills, preferred
• Familiarity with eCTD and electronic document management systems
• Strong communication, project management and interpersonal skills are essential

The incumbent in this position may be required to perform other duties, as assigned.

The pay range for this position at commencement of employment is expected to be between $130,000 – $153,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, commissions, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. 

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

#Location-Princeton,NJ #LI-Hybrid