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Job Summary

The Manager Regulatory Operations coordinates 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 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 5 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 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 $102,101.00 - Maximum $145,970.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits : comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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 Accommodation Request.

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.