Demo

MANAGER, REGULATORY AFFAIRS STRATEGY

Taiho Oncology, Inc.
NJ Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 5/29/2025

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 email People@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
  • Apply Now

    Salary : $130,000 - $153,000

    If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
    Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

    What is the career path for a MANAGER, REGULATORY AFFAIRS STRATEGY?

    Sign up to receive alerts about other jobs on the MANAGER, REGULATORY AFFAIRS STRATEGY career path by checking the boxes next to the positions that interest you.
    Income Estimation: 
    $140,918 - $196,956
    Income Estimation: 
    $188,947 - $264,846
    Income Estimation: 
    $176,359 - $246,541
    Income Estimation: 
    $158,728 - $233,218
    Income Estimation: 
    $77,272 - $101,684
    Income Estimation: 
    $95,800 - $126,196
    Income Estimation: 
    $97,803 - $128,184
    Income Estimation: 
    $95,508 - $129,349
    Income Estimation: 
    $95,800 - $126,196
    Income Estimation: 
    $122,529 - $166,597
    Income Estimation: 
    $123,229 - $164,502
    Income Estimation: 
    $123,155 - $167,827
    Income Estimation: 
    $129,372 - $180,667
    Income Estimation: 
    $188,947 - $264,846
    Income Estimation: 
    $176,359 - $246,541
    Income Estimation: 
    $158,728 - $233,218
    Income Estimation: 
    $66,241 - $89,540
    Income Estimation: 
    $77,272 - $101,684
    Income Estimation: 
    $78,084 - $104,270
    Income Estimation: 
    $75,043 - $100,052
    View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

    Job openings at Taiho Oncology, Inc.

    Taiho Oncology, Inc.
    Hired Organization Address Princeton, NJ Intern
    Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve t...
    Taiho Oncology, Inc.
    Hired Organization Address Princeton, NJ Full Time
    Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve t...
    Taiho Oncology, Inc.
    Hired Organization Address Princeton, NJ Intern
    Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve t...
    Taiho Oncology, Inc.
    Hired Organization Address Princeton, NJ Full Time
    Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve t...

    Not the job you're looking for? Here are some other MANAGER, REGULATORY AFFAIRS STRATEGY jobs in the NJ area that may be a better fit.

    Manager, Regulatory Affairs

    Regulatory Affairs Professionals Society, Marietta, GA

    Senior Director, Chemical Mgmt, Regulatory Policy & Strategy

    Regulatory Affairs Professionals Society, Washington, DC

    AI Assistant is available now!

    Feel free to start your new journey!