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Sr. Director, Regulatory Affairs Strategy
3 months ago
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:
Taiho Oncology is a Japanese company specializing in the development and commercialization of orally administered anti-cancer agents. 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. We hold ourselves and each other to a high bar of executional excellence because patients are counting on us. 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 of 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. For this position, 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.
- Advanced degree in life science or health related or pharmaceutical field.
- 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.
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.
#Pleasanton, CA
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 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.
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