Vice President, Global Regulatory Affairs

Position SummaryThe Vice President, Global Regulatory Affairs (GRA) is a key member of the R&D leadership team, responsible for setting and executing the global regulatory vision and strategy across all therapeutic areas and product portfolios. Reporting into the Sr. Vice President, Global R&D Evidence, this role provides enterprise-wide leadership for all Global Regulatory Affairs activities including, Global Regulatory Strategy, Global CMC, Global Labeling, Global Medical Writing, Global Regulatory Operations & Clinical Transparency, Global Regulatory Technology and Global Regulatory Projects. The VP will drive regulatory innovation, ensure alignment with evolving global regulatory landscapes, and foster a high-performing, globally integrated regulatory organization that supports Otsuka's mission to deliver transformative therapies to patients worldwide. Key ResponsibilitiesProvide strategic regulatory leadership and guidance to global project teams, ensuring alignment with corporate objectives and regulatory requirements.Lead the development and execution of global regulatory strategies for all development programs, ensuring timely and successful regulatory submissions and approvals.Represent the company in high-level interactions with global regulatory authorities (e.g., FDA, EMA, PMDA), leading negotiations and ensuring alignment with regulatory expectations.Oversee the preparation and submission of regulatory documents including INDs, CTAs, NDAs, BLAs, MAAs, and post‐marketing submissions.Develop and implement regulatory policies, procedures, and governance frameworks to ensure compliance and operational excellence.Proactively anticipate and mitigate regulatory risks while maintaining current knowledge.Lead regulatory intelligence and policy initiatives to anticipate and respond to changes in the global regulatory environment.Build and lead a high-performing global regulatory team, fostering a culture of innovation, collaboration, and continuous improvement.Develop and manage the Global Regulatory Affairs department's budget.Collaborate cross‐functionally with R&D, Commercial and Shared Services teams to align regulatory strategies with business goals.Participate in due diligence and business development activities, providing regulatory assessments and strategic input.Knowledge, Skills, and CompetenciesDeep knowledge of global regulatory requirements, processes, and health authority expectations.Proven ability to develop and execute global regulatory strategies across multiple regions and product types.Strong leadership, communication, and negotiation skills with the ability to influence at all levels of the organization.Demonstrated success in leading regulatory teams and managing complex regulatory submissions.Strategic thinker with strong analytical and problem‐solving skills.Proficiency in Microsoft Office Suite and regulatory systems.Education and ExperienceAdvanced degree (PharmD, PhD, MD, or equivalent) in a scientific discipline preferred.Minimum of 20 years of experience in regulatory affairs or related areas within the pharmaceutical or biotechnology industry.Significant experience in global regulatory submissions and interactions with major health authorities.Demonstrated leadership experience managing global teams and regulatory functions.Travel (approximately 30%) may be required. CompetenciesAccountability 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. Application DeadlineThis will be posted for a minimum of 5 business days. Company benefitsComprehensive 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; https://www.otsuka‐us.com/careers‐join‐otsuka. DisclaimerThis job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 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 Accommodation Request (EEAccommodations@otsuka‐us.com). Statement Regarding Job Recruiting Fraud ScamsAt Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka willneverask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. 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If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities. 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.#J-18808-Ljbffr