Taiho Oncology, Inc. · 4 days ago
Sr. Manager, Regulatory Affairs Strategy
Princeton, NJ
Full-time
Hybrid
Senior Level
$176K/yr - $207K/yr
5+ years expTaiho Oncology, Inc. is dedicated to improving the lives of patients with cancer. The Sr. Manager, Regulatory Affairs Strategy will independently prepare and direct global regulatory affairs activities, providing guidance during drug development and commercialization processes, while ensuring compliance and regulatory integrity.
BiotechnologyHealth CareMedicalOncologyPharmaceutical
Responsibilities
Manage and support the preparation, review, and submission of all components of regulatory submissions as assigned, including INDs and amendments, CTAs, marketing applications (NDA/MAA), annual reports, safety reports, etc
Support planning and executing regulatory submissions requiring cross-functional collaboration and alignment
Prepare, submit and track submissions
Establish, manage, and maintain a knowledge base of current and emerging clinical regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues
Assure 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 the regulatory activities
Conduct risk assessments of global clinical regulatory issues
Qualification
Required
College degree in life science or health related or pharmaceutical field, or the equivalent
Minimum of 5 years' experience working in pharmaceutical Regulatory Affairs
Experience with the development (IND/ CTA) and/or registration (NDA/ MAA) stage
Familiarity with eCTD and proficient in accessing documentation utilizing multiple electronic systems
Knowledge of the drug development process, drug laws, global regulations and requirements
Strong analytical skills, problem solving ability and presentation skills required
Highly effective oral and written communication skills
Excellent attention to detail and accuracy
Flexibility and ability to prioritize and manage multiple tasks simultaneously
Proficiency using Microsoft Office products and electronic systems is required
Preferred
Familiarity with project management principles is a plus
Experience with documentation systems is a plus
Benefits
Annual bonus/incentive comp plans
Potential long term incentive plan
Discretionary awards
Full range of medical, financial, and/or other benefits
401(k) eligibility
Various paid time off benefits, such as vacation, sick time, and parental leave
Company
Taiho Oncology, Inc.
The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Tim Whitten
CEO & President
Michael Schick
Senior Vice President, Chief Commercial Officer
Recent News
2025-12-03
Pharma Letter
2025-11-22
Company data provided by crunchbase