Manager, Regulatory Operations

Otsuka Pharmaceutical Co., Ltd; United States; On-site; USD 108,000 - 161,000; Full time

Benefits offered by this job

Medical, Dental & Vision

401(k) Match

Paid Holidays

Tuition reimbursement

Job summary

Otsuka Pharmaceutical Co., Ltd seeks an experienced Manager of Regulatory Operations to coordinate regulatory publishing deliverables for assigned programs, ensuring on-time submissions and adherence to health authority requirements. This role oversees staff and vendor partners, driving process improvements and maintaining lifecycle submissions.

The candidate will have 5+ years of regulatory operations experience, and deep knowledge of FDA/EMA/HC/Swiss Medic regulations, eCTD formatting,

Qualifications

• Minimum 5 years of regulatory operations experience
• Knowledge of FDA/EMA/HC/Swiss Medic regulations for electronic and paper submissions
• Experience with eCTD sequences, publishing, lifecycling and archiving

Responsibilities

• Coordinate regulatory publishing deliverables for assigned programs and products
• Act as primary liaison for regulatory publishing activities across R&D functions
• Ensure submissions are on time, within budget and comply with health authority requirements
• Provide leadership and guidance to staff and vendors to ensure quality control of submission documents

Skills

Regulatory operations

Project management

Documentation

Cross-functional collaboration

Education

Regulatory Affairs Certification (RAC)

Tools

DocuBridge

InSight Publisher

GlobalSubmit Validate

GlobalSubmit Review

ISIToolbox

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.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.**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.