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

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

• Provide global regulatory expertise to pre-clinical, clinical, and commercial areas for investigational and marketed products
• Develop and lead global regulatory strategies, plans, and executions for investigational and marketed prescription drug submissions
• Collaborate with Regulatory Management to establish clear regulatory pathways and create accurate and timely documents for submission and final approval
• Identify the need and obtain regulatory intelligence, research precedent approvals, and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products
• Translate complex pertinent global requirements and provide an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed
• Lead Cross-Functional Teams to collaboratively develop a global regulatory plan, address global regulatory issues, respond to health authority queries, and meet regulatory obligations
• Develop and lead strategy for Health Authority interactions/communications through submissions and responses to regulatory authorities within company timelines and in accordance with regulations and guidelines
• Review submission documents to ensure they are aligned with the strategic approach developed by the cross-functional team
• Support the development of strategies, draft responses, and/or review responses and documents intended for submission to FDA or other health authorities to assure compliance with regulatory standards

Essential Qualifications

• Bachelor's degree with 8+ years of experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in the pharmaceutical or healthcare-related industry
• Comprehensive knowledge of the drug development process, drug laws, global regulations, and guidelines
• Good understanding of global regulatory agencies
• Experience leading submission of CTA, IND, sNDA/NDA/MAA/Variation
• Strong information searching, summarization, and assessment skills
• Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
• Strong analytical skills and problem-solving ability
• Strong communication and presentation skills

Preferred Qualifications

• Direct or indirect supervisory and medical device experience a plus
• Experience with FDA, other health authority, or project meetings/interactions desirable

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!