Senior Director, Global Regulatory Strategy

Remote Full time

R12948

Position Summary The Senior Director, Global Regulatory Strategy is a senior regulatory executive responsible for providing strategic leadership and oversight for a therapeutic area portfolio of development and marketed products. This role is responsible for leading execution of individual products and portfolio-wide regulatory strategies that enable efficient product development, successful global registrations, and maximized asset value throughout the product lifecycle. As a member of the Global Regulatory Leadership Team, the Senior Director serves as the regulatory leader for portfolio planning, governance, and risk management activities, ensuring alignment between global regulatory strategy, development priorities, and global business objectives by driving enterprise decision-making, optimizing regulatory pathways, and proactively manage portfolio risks, while building organizational regulatory capabilities. Key Responsibilities Regulatory Strategy and Portfolio Leadership Provide strategic leadership for assets in a therapeutic area portfolio, ensuring global regulatory strategies are appropriate across development, registration, commercialization, and lifecycle management activities. Support with establishing an integrated regulatory vision and long-term strategy that supports portfolio objectives, optimizes development pathways, and maximizes each products value globally. Drive individual asset and portfolio-level regulatory decision-making by evaluating benefit-risk profiles, development opportunities, competitive landscapes, and emerging regulatory trends. Identify, assess, and proactively manage regulatory risks and opportunities across assets in the portfolio, recommending mitigation strategies and contingency plans. Ensure appropriate regulatory positions, messaging, and strategic approaches across multiple programs and regions to ensure products with the portfolio align with business objectives. Incorporate regulatory intelligence, health authority precedents, and evolving global requirements into portfolio strategy and investment decisions. Regulatory Submissions and Lifecycle Management Provide strategic oversight for major global regulatory milestones, including INDs, CTAs, NDAs, BLAs, MAAs, label expansions, and significant post-approval submissions. Ensure regulatory submission strategies support overall asset and portfolio objectives and are aligned with global development plans. Oversee regulatory planning and execution across multiple programs to ensure timely submissions, approvals, and lifecycle deliverables. Guide development of regulatory positions and review critical regulatory documents, agency responses, and submission content for strategic alignment and quality for all submissions Drive global lifecycle management strategies that enhance product value, expand indications, and maintain regulatory compliance. Health Authority Interactions Establish and oversee global health authority engagement strategies across the therapeutic area portfolio. Lead high-impact agency interactions involving significant regulatory, scientific, or business implications. Serve as the senior regulatory advisor for meetings with global regulatory authorities. Provide strategic direction for briefing packages, regulatory negotiations, and responses to complex agency questions. Foster productive relationships with health authorities to facilitate successful development and registration outcomes. Cross-Functional and Organizational Leadership Serve as the senior regulatory representative on therapeutic area portfolio governance committees, development leadership teams, and strategic planning forums. Partner with Clinical Development, Medical Affairs, Regulatory CMC, Quality, Safety, Commercial, Market Access, and Program Leadership to drive integrated decision-making. Serve as a Global Regulatory lead as well as leading, developing, and mentoring other Global Regulatory Leads and regulatory team members, creating a high-performing and collaborative regulatory organization. Ensure appropriate resource allocation, succession planning, and capability development across the therapeutic area. Provide regulatory expertise and recommendations to support enterprise decision-making . Champion a culture of accountability, innovation, and operational excellence within the regulatory function. Compliance and Continuous Improvement Ensure regulatory activities are conducted in compliance with applicable global regulations, company policies, and quality standards. Lead initiatives to enhance regulatory effectiveness, operational efficiency, and organizational performance. Drive development and implementation of regulatory best practices, standards, and governance processes. Promote inspection readiness and a culture of continuous improvement across the organization. Contribute to the evolution of the global regulatory function through strategic initiatives, process optimization, and organizational transformation efforts. Qualifications Advanced degree in a scientific discipline required; PhD, PharmD, MD, or equivalent preferred. Minimum 15 years of progressive regulatory affairs experience within the pharmaceutical or biotechnology industry. Significant experience developing and leading global regulatory strategies across multiple development and commercial programs. Demonstrated success influencing portfolio-level decisions and achieving regulatory approvals in major global markets. Proven track record leading complex health authority interactions, negotiations, and regulatory risk-management activities. Experience leading and developing high-performing regulatory teams and managing organizational priorities. Strong understanding of portfolio governance, strategic planning, and cross-functional drug development processes. Knowledge and Skills Expert knowledge of global drug development, regulatory frameworks, and registration requirements across major markets. Demonstrated ability to develop and execute portfolio-level regulatory strategies in a complex global environment. Strong business acumen with the ability to balance regulatory, scientific, operational, and commercial considerations. Expertise in regulatory risk assessment, scenario planning, and strategic decision-making. Exceptional leadership, influencing, negotiation, and stakeholder management skills. Proven ability to operate effectively at executive and governance levels. Strong people leadership capabilities, including organizational development, coaching, and talent management. Excellent communication and presentation skills with experience interacting with senior executives and global health authorities. Ability to lead through complexity, ambiguity, and organizational change while maintaining strategic focus. Competencies Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development - Play an active role in professional development as a business imperative. Minimum $230,720.00 - Maximum $345,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. Application Deadline : This will be posted for a minimum of 5 business days. Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; . Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting View email address on click.appcast.io . Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., 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. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute. #J-18808-Ljbffr Otsuka America Pharmaceutical Inc.