Sr. Manager, 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:


Join our dynamic and expanding mid-size company as a Sr. Manager, Regulatory Affairs Strategy. In this role, you will support submissions for various developmental, life cycle, and post-approval projects in the US, EU, Canada, and beyond. You will work closely with colleagues from the US, EU, and Japan, gaining valuable global experience while contributing to cancer patients' lives. Our company's size allows for direct interaction with various functions within our organization, providing a comprehensive, hands-on experience. You will have the opportunity to enhance and showcase your skills in an inclusive environment that encourages continuous learning and professional growth.

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 conducts regulatory activities to ensure high quality, regulatory integrity and completeness of all projects, supporting IND, CTA, NDA, MAA submissions.

Performance Objectives:

• 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

Education/Certification Requirements:

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

Knowledge, Skills, and Abilities:

• 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
• Familiarity with project management principles is a plus
• Proficiency using Microsoft Office products and electronic systems is required; experience with documentation systems is a plus

The pay range for this position at commencement of employment is expected to be between $175,950 - $207,000 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 annual bonus/incentive comp plans, potential long term incentive plan, 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 a candidate/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.



#Location-Princeton,NJ #LI-Hybrid 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 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 [email protected] . 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.

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