Senior Manager, Regulatory Operations

As an integral member of Otsuka’s regulatory operations team, the Senior Manager Regulatory Operations provides regulatory publishing and submission assignments, monitoring, and oversight, and leads or supports Global Regulatory Affairs (GRA) efforts.

Responsibilities

• Ensures assigned submissions are completed with quality, on time, and within established budgets.
• Acts as primary liaison coordinating regulatory publishing activities for all R&D functions and affiliates for defined content.
• Owns delivery of electronic regulatory submissions, ensuring processes are followed and quality and timelines meet health authority requirements and Otsuka leadership schedules.
• Designs and implements processes and systems to maximize electronic lifecycle/maintenance submissions, focusing on continuous improvement.
• Ensures submission and archival activities are compliant and efficient.
• Collaborates with alliance partners to achieve corporate objectives for shared dossier development, submission, and archival.
• Supervises staff to assure quality control checks of documents intended for submission and compliance with electronic regulatory standards.
• Oversees project team members for assigned submissions, including work assignments to vendor partners.
• Provides leadership and guidance for Process Mapping Teams (e.g., Regulatory Submissions, Annual Reports).
• Develops and maintains assigned regulatory operations work instructions.
• Establishes and builds collaborative relationships with colleagues.
• Organizes and maintains regulatory files.
• Provides regulatory publishing guidance to other departments/functions.

Requirements

• Minimum of 7 years of regulatory operations experience with in-depth, first-hand experience in application electronic submissions.
• Recent experience with NDAs/MAAs is essential.
• Knowledge of FDA, EMA, Health Canada, and Swiss Medic regulations and guidance for electronic and paper submissions.
• Expertise in regulatory operations, including formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences.
• Demonstrated performance in managing and producing time-intensive deliverables.
• Expert knowledge of Document Management Systems (Documentum preferred) and publishing tools (e.g., DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, ISIToolbox).
• Strong computer skills with demonstrated experience in Microsoft Office suite (Word, Excel, Access, PowerPoint) and SharePoint.
• Experience in developing processes across multiple departments/divisions leveraging technology.

Preferred Qualifications

• Demonstrated performance in managing and producing quality time-intensive deliverables.
• Strong influencing skills and experience with outsourcing.
• Proven staff management skills.
• Ability to solve complex issues through innovative problem-solving.
• Well-defined written and oral communication skills.
• Knowledge of how/when to apply organizational policy or procedures to various situations.
• Demonstrated flexibility in dealing with change and diversity.
• Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment.
• Successful engagement in multiple initiatives simultaneously.
• Certification (e.g., Regulatory Affairs Professionals Society (RAPS)).
• Prior project management experience.

Skills

• 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 on customers, patients, employees, and the business.
• Patient & Customer Centricity: Maintain an ongoing focus on the needs of customers and/or key stakeholders.
• Impactful Communication: Communicate with logic, clarity, and respect to influence at all levels and 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.

Pay

Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity. The range shown represents a typical pay range or starting pay for individuals 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 the role.

Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company-provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Additional company-provided benefits.