Senior Manager, Regulatory Operations

Otsuka Pharmaceutical Co., Ltd; Princeton (KY); On-site; USD 150,000 - 224,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) with company match

Paid time off and holidays

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking a Sr. Mgr Regulatory Operations to lead coordination of high‑quality regulatory publishing deliverables and ensure on-time submissions across FDA/EMA guidelines.

You will oversee electronic submissions, lifecycle management, and archival activities, while guiding teams and coordinating with alliance partners to meet corporate objectives. The role emphasizes process design, cross‑functional collaboration, and strong knowledge of regulatory requirements

Qualifications

• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions
• Excellent knowledge and experience 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 (DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox)
• Strong computer skills with demonstrated experience in Microsoft Office suite and SharePoint
• NDAs/MAAs experience essential
• Minimum of 7 years of regulatory operations experience with first-hand electronic submissions

Responsibilities

• Coordinate regulatory publishing deliverables on time and with high quality
• Lead or support GRA efforts and regulatory submissions monitoring
• Act as liaison for regulatory publishing across R&D functions
• Publish and archive electronic submissions per health authority requirements
• Design processes to maximize electronic lifecycle submissions
• Supervise staff and coordinate with vendors on submissions
• Provide leadership for regulatory process mapping and work instructions
• Develop and maintain regulatory operations documentation

Skills

FDA regulations

EMA regulations

Regulatory submissions

Document management

Tools

Documentum

DocuBridge

Insight Publisher

GlobalSubmit

ISIToolbox

Microsoft Office

SharePoint

Job description

Job Summary

The Sr. Mgr Regulatory Operations is responsible for the coordination of high quality and on-time regulatory publishing deliverables in line with the strategic direction of their assigned programs/products, identifies impact of agency guidance updates relevant to submission process, and drives innovative process change for improved efficiency.

Job Description

As an integral member of Otsuka’s regulatory operations team, provides regulatory publishing and submission assignments, monitoring, and oversight, as well as a lead or support for GRA efforts

Ensures assigned submissions are made with quality, on-time, and within established budgets

Acts as primary liaison while coordinating regulatory publishing activities for all R&D functions

Liaise with affiliates for coordinating and publishing defined content

Owns delivery of electronic regulatory submissions to ensure processes are followed, as well as quality and timelines are met in accordance with health authority requirements and Otsuka leadership established schedules

Designs and implements processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuous improvements

Ensures submission and archival activities

Collaborates with alliance partners to achieve corporate objectives for shared dossier development, submission, and archival activities

Supervises staff to assure quality control checks of documents intended for submission to regulatory agencies 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., Key stakeholder for Regulatory Submissions, Key stakeholder for Annual Reports)

Develops and maintains assigned regulatory operations work instructions

Establishes and builds collaborative relationships with colleagues

Responsible for organizing and maintaining regulatory files

Provides regulatory publishing guidance to other departments / functions

Qualifications

Required

Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions

Excellent knowledge and experience 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, and ISIToolbox)

Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint

Knowledge in developing processes across multiple departments/divisions that leverage technology

Recent experience with NDAs / MAAs is essential

Minimum of 7 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions

Preferred

Demonstrated performance in managing and producing quality time-intensive deliverables

Strong influencing skills and experience with outsourcing

Strong staff management skills

Proven ability to solve complex issues through innovative problem solving

Well defined written and oral communication skills

Knowledge how/when to apply organizational policy or procedures to a variety of 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 (such as Regulatory Affairs Professionals Society (RAPS))

Prior project management experience

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 $150,034.00 - Maximum $224,250.00, 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 & Benefits

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://ah-prod.com/multi/videoplayer/player.html?v=6385356920112.

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Disclaimer: This 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 [e-mail].

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