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|Manager, Regulatory Operations|
Company: Otsuka Pharmaceuticals
Location: Princeton, NJ
Employment Type: Full Time
Date Posted: 09/22/2022
Expire Date: 11/22/2022
Job Categories: Healthcare, Other
Manager, Regulatory Operations|
The 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.
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
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
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
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
Valid Proof of COVID-19 Vaccination or Accommodation
The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.
Statement Regarding Job Recruiting Fraud Scams
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.