Sr. Director, Regulatory Affairs StrategyPrinceton, NJ, USA Req #329 Tuesday, March 12, 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. 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: The incumbent will be assigned to lead one or two high priority late-phase clinical development programs as Global Regulatory Lead (GRL), responsible for leading regulatory sub-team and all regulatory activities including marketing authorization filing and approval in US and Europe. Position Summary: The incumbent is the most senior regulatory person on project teams and is responsible for regulatory activities globally except for Japan and Asia. For assigned projects and products, the Senior Director, Regulatory Affairs Strategy is responsible for strategic definition/direction, and implementation of regulatory strategies, and ensures that these strategies are consistent with company objectives. The incumbent directs the project/product teams’ regulatory activities to ensure high quality, regulatory integrity, and completeness of all projects. The incumbent is responsible for providing guidance and directing all regulatory activities during drug development, approval and post approval process and for commercialization, in coordination with both internal staff and external consultants and contractors. Performance Objectives:
Responsible to represent the Regulatory Affairs position and decision in assigned Project Teams, due diligence assessments, and compliance remediations for Taiho Oncology, Inc., (TOI), projects including exploratory development and commercialization.
Develop and implement regulatory strategies and compliance activities for global clinical development for assigned projects to ensure the preparation and review of all submissions to regulatory authorities globally except for Japan and Asia.
Expected to partner across RA globally to ensure alignment and consistent messaging across regulatory team members, regulatory subgroups, and regions
Author, review, and approve regulatory submission documents, including regulatory correspondence with Health Authorities
Lead or co-lead Health Authority interactions, meetings, negotiations
Responsible to manage junior RA talent directly as line manager and indirectly through role modeling and mentoring
Responsible for oversight of external regulatory consultants and CROs and ensuring direction and coordination of their regulatory activities.
Provide regulatory guidance and support to Clinical, Medical and Safety teams.
Together with Quality Assurance, manage regulatory compliance for sponsor activities for drug supply, documentation, GMP and GCP requirements.
Prepare project and/or status reports.
This position requires travel.
Education/Certification Requirements:
Advanced degree in life science or health related or pharmaceutical field.
Knowledge, Skills, and Abilities:
Extensive previous experience in Regulatory Affairs (both US and EU) in clinical drug development and regulatory filings for drugs preferably some experience in oncology.
Previous experience managing regulatory affairs functional areas and external CROs and consultants.
Substantial experience developing and implementing regulatory strategy for all stages of clinical development (preclinical to commercial).
Substantial knowledge of and experience interacting and negotiating with US, EU and other regulatory agencies.
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 others.
Good organizational and planning skills; drive for results.
Excellence in written and oral communication.
Ability to reason, persuade and negotiate with regulatory authorities.
Ability to read, analyze and interpret scientific and technical information.
Effective analytical/problem solving skills.
Working knowledge of project management.
Ability to read, analyze, and interpret scientific and technical journals and legal documents.
Ability to respond to inquiries or complaints from regulatory agencies.
Ability to write procedures. Ability to effectively present information to internal and external clients.
The pay range for this position at commencement of employment is expected to be between $240,000 - $283,000 annually; 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, 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 PTO, 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.
Princeton, NJ, USA
