Manager, Regulatory Operations

🕒 September 21

🇺🇸 United States – Remote

💵 $107.7k - $161k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 1%

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Coordinate high-quality and on-time regulatory publishing deliverables aligned with assigned programs/products • Identify impacts of agency guidance updates relevant to submission processes • Drive innovative process changes to improve efficiency • Provide regulatory publishing and submission assignments, monitoring, and oversight • Lead or support GRA efforts • Ensure assigned submissions are delivered with quality, on time, and within established budgets • Act as primary liaison coordinating regulatory publishing activities for R&D functions • Liaise with affiliates to coordinate and publish defined content • Own delivery of electronic regulatory submissions and ensure compliance with health authority requirements and established schedules • Design and implement processes and systems to maximize electronic lifecycle and maintenance submissions • Ensure submission and archival activities • Direct staff and contingent workers performing document quality-control checks and ensuring compliance with electronic regulatory standards • Oversee project team members and work assignments to vendor partners • Lead and guide Process Mapping Teams • Develop and maintain regulatory operations work instructions • Build collaborative relationships with colleagues • Organize and maintain regulatory files • Provide regulatory publishing guidance to other departments and functions

🎯 Requirements

• Minimum of 5 years of regulatory operations experience • In-depth first-hand experience with application electronic submissions • Knowledge of FDA, EMA, Health Canada, and Swissmedic 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, with Documentum preferred • Experience with publishing tools such as DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox • Strong computer skills and demonstrated experience with Microsoft Office suite (Word, Excel, Access, and PowerPoint) and SharePoint • Knowledge of developing technology-leveraged processes across multiple departments/divisions • Recent experience with NDAs/MAAs is essential • Strong staff management skills • Proven ability to solve complex issues through innovative problem solving • Well-defined written and oral communication skills • Ability to work effectively in a global, matrixed, multicultural, collaborative environment • Ability to engage successfully in multiple initiatives simultaneously • Certification such as Regulatory Affairs Professionals Society (RAPS) certification preferred • Prior project management experience preferred

🏖️ Benefits

• Incentive opportunity • Comprehensive medical coverage • Dental coverage • Vision coverage • Prescription drug coverage • Company-provided basic life insurance • Accidental death & dismemberment insurance • Short-term disability insurance • Long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs

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