Job Information
Taiho Oncology Associate Director, Regulatory Affairs Operations in USA ● Princeton, New Jersey
Associate Director, Regulatory Affairs Operations
Pleasanton, CA, USA ● Princeton, NJ, USA
Req #386
Tuesday, August 20, 2024
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 oncology company in the role of Associate Director, Regulatory Affairs Operations where you will utilize your knowledge and experience to build a stronger Regulatory Operations team by providing guidance, as well as regulatory system and process support for the US and Europe. At Taiho Oncology our mission is to improve the lives of patients with cancer, their families, and their caregivers. Whether it’s our patients or employees, people come first at Taiho. 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. Our culture is inclusive, and our leadership ensures an environment which encourages employees to be accountable for their own successes. Collaboration and trust are additional core principles operating at Taiho which sets us apart from other organizations. These principles foster open communication and fun atmosphere. Respect, dignity, compassion and kindness are required of each employee. We believe that honesty and integrity are critical to our business and our actions earn each other’s trust and the trust of the community we serve.
Position Summary:
Under the leadership of Regulatory Affairs the incumbent manages global regulatory operational activities (except Asia) for all Taiho Oncology, Inc., (TOI) projects, provides strategic regulatory operational guidance during drug development, approval, post approval, and commercialization, in coordination with internal staff and external consultants/contractors. Coordinate the publishing and submission of electronic documents to regulatory authorities. This role is responsible to manage and coordinate the tracking, publishing, submission and archiving of electronic documents provided to regulatory authorities as well as manage the operational aspects of US, Canada and European eCTD filings directly or through third party representation. Responsible to maintain working knowledge of Regulatory Information Management including evolving EU data requirements. This role leads and participates in Process Improvement initiatives for Regulatory Affairs and TOI Development. May also be responsible for vendor and supplier proposals and bid negotiation.
Performance Objectives:
Provide management level guidance to the Regulatory Affairs team in the publishing and tracking of submissions.
Provide management level guidance to all functions in the preparation of regulatory documents in the eDMS (Electronic Document Management System).
Advise relevant stakeholders within the company and the Regulatory team with strategic guidance in the electronic regulatory submissions process.
Build a strong relationship with internal and external customers such as: Clinical, Biostats, Legal, Medical Affairs, Commercial, Pharmacovigilance and regulatory vendors
Support the development and implementation of procedures and processes for use of eDMS.
Responsible for providing eDMS related training and support, as required by the organization.
Support the development and implementation of procedures and process for use of a Registration Tracking System.
Maintain a high level of knowledge of regulatory requirements for electronic submissions and industry trends and standards and remain current with evolving standards for electronic submissions.
Contributes to the development and implementation of Corporate and Department procedures to improve company performances and to align with regulatory requirements.
Assesses the impact of new regulations, guidances or enforcements and advise the Regulatory Group and TOI on requirements to maintain compliance with regulatory activities.
Fosters collaborative, efficient, and effective working relations with internal and external colleagues in order to further build the cordial working relationship between Taiho Oncology, Inc. and overall organization.
Provides input into vendor and supplier selection. Reviews contracts and bid solicitation to achieve quality and cost-effective external support.
Prepare project and/or status reports as required.
May manage direct reports
This position may require 5-10% travel.
Education/Certification Requirements:
- College degree in life science or health related or pharmaceutical field, or the equivalent.
Knowledge, Skills, and Abilities:
6-10 years of pharmaceutical industry experience in developing and implementing regulatory submissions strategy for early and late stage of development products with strong emphasis of approval through launch to post marketing commercial support.
Technical expertise in handling electronic document management system (eDMS).
Management experience with personnel, processes and eDMS Systems.
Thorough knowledge of electronic Common Technical Document submission requirements
Self-organizing, self-directing, highly motivated with strong critical thinking and analytical skills.
Experience with vendor selection and contract review and negotiation.
Strong working knowledge of global regulatory requirements and submission processes.
Good interpersonal skills that involves working well in a team environment and the ability to lead and influence others.
Collaborative and good organizational and planning skills; results driven.
Excellence in written and oral communication.
Effective analytical/problem solving skills.
Working knowledge of project management.
Ability to read, analyze, and interpret global regulations, scientific and technical journals and legal documents.
Ability to write procedures.
Ability to effectively present information to internal and external clients.
Ability to effectively present information and respond to questions internally and externally.
Ability to work with mathematic concepts such as probabilities and statistics.
Ability to apply concepts such as proportions, fractions, percentages to practical situations.
Ability to collect information, define problems, establish facts, draw conclusions and propose feasible actions.
Knowledge of PC software, including Microsoft Office products.
While performing the duties of this job, the employee is regularly required to sit.
The employee is frequently required to talk and hear.
The employee is occasionally required to walk.
The noise level in the work environment is usually quiet.
The pay range for this position at commencement of employment is expected to be between $178,500 and $210,000 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.
#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.
Pleasanton, CA, USA
Princeton, NJ, USA