Manager, Regulatory Operations

🕒 Setembro 21

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $107.718 - $161.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 0%

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Otsuka Pharmaceutical Companies (U.S.)

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

💊 Farmacêutico

🏥 Saúde

🧬 Biotecnologia

Pharmaceuticals • Healthcare • Biotechnology

As Empresas Farmacêuticas Otsuka (EUA) são um ator proeminente na indústria de fabricação farmacêutica, dedicadas a criar produtos inovadores para uma melhor saúde em todo o mundo. A empresa é composta por duas entidades principais: a Otsuka America Pharmaceutical, Inc. (OAPI), que se concentra na comercialização de produtos descobertos e licenciados pela Otsuka na América do Norte, e a Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), que é especializada no desenvolvimento clínico e registro global de soluções inovadoras em saúde, particularmente na área de neurociências.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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