Sr. Manager, Regulatory Affairs Strategy

Sr. Manager, Regulatory Affairs Strategy

Apply for the Sr. Manager, Regulatory Affairs Strategy role at Taiho Oncology, Inc.

Taiho Oncology is on a mission to improve the lives of patients with cancer, their families, and caregivers. We emphasize a “People first” approach, valuing accountability, collaboration, and trust. Our organization works on cutting‑edge science, growing our portfolio across tumor types, and delivering innovative therapies worldwide.

This position is hybrid, with a mix of on‑site and remote work.

Join a dynamic, mid‑size company where you will support US, EU, Canada, and global regulatory submissions for developmental, lifecycle, and post‑approval projects. You will collaborate closely with colleagues across the US, EU, and Japan, gaining broad global experience and contributing directly to cancer patients’ lives.

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 in the oncology therapeutic area.

• Manage and support the preparation, review, and submission of all components of regulatory submissions, including INDs, CTAs, NDAs/MAAs, annual reports, and safety reports.
• Support planning and execution of regulatory submissions requiring cross‑functional collaboration and alignment.
• Prepare, submit, and track submissions.
• Maintain a knowledge base of current and emerging clinical regulatory requirements, guidelines, and best practices, interpreting and communicating relevant issues.
• Ensure compliance with regulatory standards and guidance documents.
• Serve as regulatory lead for assigned activities and clinical study teams.
• Provide updates to project/study teams on regulatory activities.
• Conduct risk assessments of global clinical regulatory issues.

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

• Minimum of 5 years’ experience in pharmaceutical Regulatory Affairs.
• Experience with the IND/CTA and/or NDA/MAA stages.
• Familiarity with eCTD and proficiency in accessing documentation through multiple electronic systems.
• Knowledge of the drug development process, drug laws, and global regulations.
• Strong analytical, problem‑solving, and presentation skills.
• Highly effective oral and written communication skills.
• Excellent attention to detail and accuracy.
• Ability to prioritize and manage multiple tasks simultaneously.
• Project management principles are a plus.
• Proficiency using Microsoft Office products and electronic systems.

• Seniority level:
  Mid‑Senior level
• Employment type:
  
  Full‑time
• Job function:
  Regulatory Affairs
• Industry: Pharmaceutical Manufacturing

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, 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.