Job Information
Taiho Oncology Manager, Regulatory Affairs Strategy in Princeton, New Jersey
Manager, Regulatory Affairs Strategy
Princeton, NJ, USA
Req #439
Wednesday, February 19, 2025
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 – $153,000annually. 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
Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please emailPeople@taihooncology.com. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.
The incumbent in this position may be required to perform other duties, as assigned.
Other details
Job Family R&D
Job Function Regulatory Affairs
Travel % 25
Princeton, NJ, USA
