Associate Director, Regulatory Affairs Strategy

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: 

The incumbent will be assigned to lead/support one or two clinical development programs as Regulatory Lead (RL), responsible for regulatory strategy and execution activities including IND/CTA, NDA/MAA filing in US and Europe.

Position Summary: 

• Under the direction of regulatory affairs management, the incumbent independently prepares and directs global regulatory affairs activities and provides regulatory guidance during drug development, approval and post approval processes and commercialization, in coordination with both the internal and external consultants and contractors in the oncology therapeutic area. The incumbent initiates interactions and negotiations directly with regulatory authorities during the drug development and approval processes following an agreed upon plan. The incumbent conducts the regulatory activities to ensure high quality, regulatory integrity and completeness of all projects, supporting IND, NDA, MAA, IMPD and CTA submissions.

Performance Objectives: 

• Independently directs as well as prepares global regulatory affairs strategies and executes regulatory activities for Taiho Oncology, Inc., (TOI), with general guidance from manager and regulatory affairs leadership.
• Fosters collaborative, efficient, and effective working relations with FDA (and other Health Authorities if necessary) in order to further build the cordial working relationship between Taiho Oncology, Inc. and global health authorities.
• Assesses the impact on new regulations, guidances or enforcements and advises the project teams on requirements to maintain compliance with regulatory activities with emphasis on research and development activities.
• Advises the relevant project teams and management on relevant new and existing regulatory risks and compliance requirements relevant to development aspects. Provides regulatory expertise, advice, and support to the TOI Development Organization and other product-related teams. Fosters and facilitate communication with Global Regulatory Affairs on these topics.
• Contributes to the development and implementation of Corporate and Department procedures for regulation of development programs.
• Prepare project and/or status reports as required.

Education/Certification Requirements: 

• Bachelor’s degree in pharmacy, biology, chemistry or related scientific discipline or equivalent experience is required.
• MSc, PhD or PharmD preferred.
• Optional RAC certification helpful.
• Technical and scientific expertise in a discipline related to pharmaceutical development.

Knowledge, Skills, and Abilities:

• Ten years previous experience in global regulatory affairs and regulatory submissions for drugs, preferably experience in oncology.
• Five to 7 years previous experience developing and implementing global regulatory strategies for early and late stage clinical development projects with strong emphasis on approval through launch leading to post approval commercial support.
• Previous experience managing regulatory affairs functional areas and external CROs and consultants desirable.
• Substantial knowledge of and experience interacting and negotiating with regulatory agencies, particularly the FDA.
• 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.
• Ability to:
  • Read, analyze, and interpret scientific and technical journals and legal documents.
  • Respond to inquiries or complaints from regulatory agencies.
  • Write procedures.
  • Effectively present information to internal and external clients.
  • 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.

The pay range for this position at commencement of employment is expected to be between $188,00 to $222,000 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.

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