Associate Director, Regulatory Affairs Strategy

Associate Director, Regulatory Affairs Strategy

Princeton, NJ, USA Req #415

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. 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.

Hybrid

Employee Value Proposition:

The incumbent will 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:

• Independently prepares and directs global regulatory affairs activities and provides regulatory guidance during drug development, approval and post-approval processes, in coordination with internal and external consultants and contractors in the oncology therapeutic area.
• Initiates interactions and negotiations directly with regulatory authorities during the drug development and approval processes following an agreed upon plan.
• Conducts regulatory activities to ensure high quality, regulatory integrity and completeness of all projects, supporting IND, NDA, MAA, IMPD and CTA submissions.

Performance Objectives:

• Directs and prepares global regulatory affairs strategies and executes regulatory activities for Taiho Oncology, Inc., with guidance from manager and regulatory affairs leadership.
• Fosters collaborative, efficient, and effective working relations with FDA and other Health Authorities to build a cordial working relationship.
• Assesses the impact of new regulations and advises project teams on compliance requirements.
• Advises project teams on regulatory risks and compliance requirements relevant to development aspects.
• Contributes to the development and implementation of Corporate and Department procedures for regulation of development programs.
• Prepares 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 in oncology.
• Five to 7 years previous experience developing and implementing global regulatory strategies for clinical development projects.
• Previous experience managing regulatory affairs functional areas and external CROs and consultants desirable.
• Substantial knowledge of and experience interacting 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 and effectively present information to clients.
• Apply mathematical concepts to tasks such as frequency distribution and analysis of variance.

The pay range for this position at commencement of employment is expected to be between $188,000 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. The total compensation package may also include other elements, including a sign-on bonus, restricted stock units, and various paid time off benefits.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary 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 law.

The incumbent in this position may be required to perform other duties, as assigned.