Taiho Oncology, Inc.
Associate Director, Regulatory Affairs Operations
Taiho Oncology, Inc., Princeton, New Jersey, us, 08543
Associate Director, Regulatory Affairs Operations
Pleasanton, CA, USA ● Princeton, NJ, USA
Req #386Tuesday, August 20, 2024Looking 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. 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. We invite you to join us.HybridPosition 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 for managing and coordinating the tracking, publishing, submission, and archiving of electronic documents provided to regulatory authorities as well as managing the operational aspects of US, Canada, and European eCTD filings directly or through third-party representation. Responsible for maintaining 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.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 the use of eDMS.Responsible for providing eDMS related training and support, as required by the organization.Support the development and implementation of procedures and processes for the use of a Registration Tracking System.Maintain a high level of knowledge of regulatory requirements for electronic submissions and industry trends and standards.Contributes to the development and implementation of Corporate and Department procedures to improve company performances and to align with regulatory requirements.Assess the impact of new regulations, guidances, or enforcements and advise the Regulatory Group and TOI on requirements to maintain compliance with regulatory activities.Foster collaborative, efficient, and effective working relations with internal and external colleagues.Provide input into vendor and supplier selection. Review contracts and bid solicitation to achieve quality and cost-effective external support.Prepare project and/or status reports as required.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 development products.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 involve working well in a team environment and the ability to lead and influence others.Excellence in written and oral communication.Effective analytical/problem-solving skills.Ability to read, analyze, and interpret global regulations, scientific and technical journals, and legal documents.Ability to write procedures and effectively present information to internal and external clients.Knowledge of PC software, including Microsoft Office products.The pay range for this position at commencement of employment is expected to be between $178,500 and $210,000 annually. This pay range 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.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.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.The incumbent in this position may be required to perform other duties, as assigned.
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Pleasanton, CA, USA ● Princeton, NJ, USA
Req #386Tuesday, August 20, 2024Looking 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. 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. We invite you to join us.HybridPosition 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 for managing and coordinating the tracking, publishing, submission, and archiving of electronic documents provided to regulatory authorities as well as managing the operational aspects of US, Canada, and European eCTD filings directly or through third-party representation. Responsible for maintaining 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.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 the use of eDMS.Responsible for providing eDMS related training and support, as required by the organization.Support the development and implementation of procedures and processes for the use of a Registration Tracking System.Maintain a high level of knowledge of regulatory requirements for electronic submissions and industry trends and standards.Contributes to the development and implementation of Corporate and Department procedures to improve company performances and to align with regulatory requirements.Assess the impact of new regulations, guidances, or enforcements and advise the Regulatory Group and TOI on requirements to maintain compliance with regulatory activities.Foster collaborative, efficient, and effective working relations with internal and external colleagues.Provide input into vendor and supplier selection. Review contracts and bid solicitation to achieve quality and cost-effective external support.Prepare project and/or status reports as required.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 development products.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 involve working well in a team environment and the ability to lead and influence others.Excellence in written and oral communication.Effective analytical/problem-solving skills.Ability to read, analyze, and interpret global regulations, scientific and technical journals, and legal documents.Ability to write procedures and effectively present information to internal and external clients.Knowledge of PC software, including Microsoft Office products.The pay range for this position at commencement of employment is expected to be between $178,500 and $210,000 annually. This pay range 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.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.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.The incumbent in this position may be required to perform other duties, as assigned.
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