Associate Director, Regulatory Affairs Strategy - Taiho Oncology

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 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 key person responsible for post marketing and/or development regulatory activities under the direction of Regulatory Affairs management. The incumbent plans, directs and executes the regulatory activities to ensure high quality, regulatory integrity and completeness of all assigned programs for the US Europe and Canada. The incumbent is responsible for providing guidance and directing all regulatory activities to support assigned programs for late-stage development, approval, launch and post approval processes for commercialization.  Must coordinate with both internal staff and external consultants and contractors, as well as partner divisions/companies as needed.  The incumbent initiates interactions and negotiations directly with regulatory authorities during the late-stage development and life cycle stages following agreed targets and goals. 

Performance Objectives:

• Independently manage regulatory aspects of life cycle and post marketing regulatory submissions and communications with the US Food and Drug Administration (FDA).
• Lead/support Regulatory subteam(s) for assigned projects to define and ensure execution of regulatory strategies supporting development activities and marketing registrations in US and Europe.
• Liaise with Taiho Canada organization to support regulatory aspects of life cycle and post marketing regulatory submissions and communications with Health Canada.
• Author, review, and approve regulatory submission documents, including regulatory correspondence with Health Authorities.
• Member of the Global Project Team to represent Regulatory Affairs for assigned projects/products.
• Advise the project team and other global Taiho functions on relevant new and existing regulatory risk and compliance requirements relevant to the role.  Provide regulatory expertise, advice, and support to the Taiho Commercial Organization and other product-related teams. Foster and facilitate communication with Global Regulatory Affairs on these topics, including mentoring of junior staff.
• Assess the impact on new regulations, guidances or enforcements and advise the project teams on requirements to maintain compliance with post marketing activities.
• Contribute to the development and implementation of Corporate and Department procedures for regulation of marketed promotional and brand related materials.
• Prepare project and/or status reports.

Education/Certification Requirements:

• College degree in life science or health related or pharmaceutical field, or the equivalent

Knowledge, Skills, and Abilities:

• 9-11 years of experience in US Regulatory Affairs in development, life cycle and post marketing regulatory affairs and regulatory submissions for drugs preferably with specific experience in oncology.
• Substantial experience developing and implementing regulatory strategies for late stage of clinical development with strong emphasis on approval through launch to post marketing commercial support.
• Previous experience representing regulatory affairs functional areas and overseeing external CROs and consultants.
• Substantial knowledge of and experience interacting and negotiating with US regulatory agencies.
• 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.
• Collaborative skills
• 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.
• Ability to apply mathematical concepts to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.
• 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 - $210,000 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.

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