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Sep 19, 2025

Experienced Associate Director of Global Regulatory Affairs – Leading Strategic Regulatory Guidance for Investigational and Marketed Products in the Pharmaceutical Industry

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Introduction to Otsuka Pharmaceutical Company

Otsuka Pharmaceutical Company is a global healthcare organization dedicated to improving the lives of patients and their families through innovative products and services. With a strong presence in the United States, Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Our corporate philosophy, "Otsuka-people creating new products for better health worldwide," drives our passion for discovering and developing new treatments that can make a meaningful difference in the lives of patients.

Job Overview

We are seeking an experienced Associate Director of Global Regulatory Affairs to join our team in the USA. As an Associate Director, you will provide strategic regulatory guidance and leadership in the development and execution of global regulatory strategies for investigational and marketed products. This is a remote role that offers the freedom and flexibility to work from anywhere in the USA, with occasional travel required (approximately 20%).

Key Responsibilities

Essential Qualifications

Preferred Qualifications

Skills and Competencies

The ideal candidate will possess strong leadership and collaboration skills, with the ability to work effectively in a cross-functional team environment. You will have excellent communication and presentation skills, with the ability to distill complex regulatory information into clear and concise language. You will also have strong analytical and problem-solving skills, with the ability to think critically and strategically.

Career Growth Opportunities and Learning Benefits

At Otsuka, we are committed to the growth and development of our employees. As an Associate Director of Global Regulatory Affairs, you will have the opportunity to work on complex and challenging projects, with the support of a experienced team. You will also have access to training and development programs, including mentorship, coaching, and formal training, to help you build your skills and advance your career.

Work Environment and Company Culture

Otsuka is a dynamic and innovative company, with a strong commitment to diversity, equity, and inclusion. We believe in creating a work environment that is inclusive, respectful, and supportive of all employees, regardless of their background, culture, or perspective. We also believe in recognizing and rewarding our employees for their contributions, with a comprehensive benefits package, including comprehensive medical, dental, vision, and prescription drug coverage, company-provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs.

Compensation, Perks, and Benefits

The salary range for this position is $155,838 - $232,990 per year, depending on experience, with an annual incentive bonus. We also offer a comprehensive benefits package, including comprehensive medical, dental, vision, and prescription drug coverage, company-provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs.

Conclusion

If you are a motivated and experienced regulatory professional, with a passion for leading strategic regulatory guidance and developing innovative products, we encourage you to apply for this exciting opportunity. As an Associate Director of Global Regulatory Affairs at Otsuka, you will have the chance to make a meaningful difference in the lives of patients, while working in a dynamic and innovative company with a strong commitment to diversity, equity, and inclusion. Don't miss this opportunity to join our team and take your career to the next level. Apply now!

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