Vice President, Global Regulatory Affairs

Position Summary The 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 Responsibilities

Provide 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 Competencies

Deep 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 Experience

Advanced 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.

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.

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; https://www.otsuka‑us.com/careers‑join‑o