Senior Manager, Regulatory Operations

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

Benefits offered by this job

401(k) match

Paid holidays

Paid leave programs

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking a Senior Regulatory Operations Manager to lead the coordination of regulatory publishing and submissions across R&D programs. The role focuses on timely, quality deliverables and continuous process improvements, with collaboration across affiliates and vendors.

Responsibilities include overseeing electronic submissions, lifecycle maintenance, and archival activities, while ensuring adherence to health authority requirements and internal schedules.

Qualifications

• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions
• Expert knowledge of document management systems (Documentum preferred) and publishing tools (DocuBridge, InSightPublisher, GlobalSubmitValidate, GlobalSubmitReview, and ISIToolbox)
• Experience with NDAs / MAAs is essential
• Minimum 7 years of regulatory operations experience and in-depth firsthand experience with electronic submissions
• Proven track record delivering time-intensive regulatory deliverables

Responsibilities

• Provide regulatory publishing and submission assignments, monitoring, oversight, and leadership or support for GRA efforts
• Ensure submissions are on-time, high quality, and within budgets
• Coordinate regulatory publishing activities for all R&D functions and liaise with affiliates
• Own delivery of electronic regulatory submissions meeting authority requirements and schedules
• Design and implement processes to maximize electronic lifecycle/submission maintenance
• Oversee submission archival activities and collaborate with alliance partners
• Supervise staff as needed to ensure quality control of submission documents
• Develop and maintain regulatory operations work instructions and processes
• Establish collaborative relationships and organize regulatory files

Skills

Regulatory operations

Regulatory submissions

Project leadership

Documentation standards

Tools

Documentum

DocuBridge

InSightPublisher

GlobalSubmitValidate

GlobalSubmitReview

ISIToolbox

Microsoft Office

SharePoint

Job description

Job Summary

The Sr.MgrRegulatoryOperationsis responsible for thecoordination of high quality and on-time regulatory publishing deliverables in line with the strategic direction of their assigned programs/products, identifies impactof 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, providesregulatory publishing and submissionassignments, monitoring,andoversight, as well as alead orsupport 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 withaffiliatesfor coordinating and publishingdefinedcontent

• Owns delivery of electronic regulatory submissions to ensure processes are followed, as well as qualityand timelines are metin accordance withhealth authority requirements and Otsuka leadershipestablishedschedules

• Designsand implements processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuousimprovements

• Ensures submission and archival activities

• Collaborates withalliance partners to achieve corporateobjectivesfor 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 andmaintainsassigned regulatory operations work instructions

• Establishes and builds collaborative relationships with colleagues

• Responsible for organizing andmaintainingregulatory files

• Providesregulatory 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,InSightPublisher,GlobalSubmitValidate,GlobalSubmitReview, andISIToolbox)

• Strong computer skills withdemonstratedexperience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint

• Knowledge in developing processes across multiple departments/divisions thatleveragetechnology

• Recent experience with NDAs /MAAsis 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

• Strongstaff management skills

• Proven ability to solve complex issues through innovative problem solving

• Well defined written and oral communication skills

• Knowledgehow/when to apply organizational policy or procedures to a variety of situations

• Demonstratedflexibility in dealing with change and diversity

• Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment

• Successful engagementin 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 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.

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].