Manager, Regulatory Operations

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 108,000 - 161,000; Full time

Benefits offered by this job

401(k) match

Tuition reimbursement

Paid holidays

Paid leave programs

Job summary

Otsuka Pharmaceutical Companies (U.S.) is seeking a Manager of Regulatory Operations to coordinate high-quality regulatory publishing deliverables in line with program strategy. The role drives process improvements, liaises with R&D functions, and ensures timely electronic submissions in compliance with FDA/EMA/HC/Swiss Medic guidelines.

The position requires leadership in document management systems and publishing tools, with focus on lifecycle maintenance and archival activities across global

Qualifications

• Minimum of 5 years in regulatory operations with hands-on electronic submissions.
• Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidelines for submissions.
• Expert in regulatory operations: formatting, publishing, lifecycling, archiving (eCTD).
• Experience managing time-intensive deliverables.
• Strong familiarity with Documentum and publishing tools.
• Proficient in MS Office and SharePoint.
• Experience with NDAs/MAAs is essential.

Responsibilities

• Coordinate regulatory publishing and submission assignments.
• Ensure on-time, within-budget submissions with quality.
• Lead or support GRA efforts and liaison for R&D functions.
• Coordinate publishing with affiliates and vendor partners.
• Deliver electronic regulatory submissions per health authority requirements.
• Design processes to optimize electronic lifecycle submissions and continuous improvements.
• Oversee submission activities, including archives and staff guidance.
• Develop work instructions and build cross-department collaboration.

Skills

Regulatory publishing

FDA/EMA/HC/Swiss Medic

eCTD knowledge

Documentum

DocuBridge

InSight Publisher

GlobalSubmitValidate

GlobalSubmitReview

ISIToolbox

MS Office & SharePoint

NDAs/MAAs

Tools

Documentum

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

Microsoft Office

SharePoint

Job description

Job Summary

The Manager 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
• Provides direction to staff and contingent workers 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

• Minimum of 5 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions
• 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

Preferred

• Demonstrated performance in managing and producing quality time-intensive deliverables
• 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.

Salary

Minimum $107,718.00 - Maximum $161,000.00, 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.

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.

Equal Opportunity

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].