Manager, Regulatory Operations

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $107.7k - $161k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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