Senior Manager, LRBO Regulatory Operations

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $134.6k - $201.3k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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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

• Manage and execute FDA promotional submission activities, including preparation, assembly, tracking, and submission of required materials • Prepare launch-related submission packages and supporting documentation • Perform independent operational quality control for submission completeness, accuracy, required components, and document versions • Coordinate planning, preparation, and submission of materials to OPDP for advisory review • Maintain regulatory submission records, documentation, and correspondence • Develop and maintain submission checklists, templates, and reference materials • Identify and resolve submission-related operational issues and escalate material risks or delays with recommended solutions • Collaborate with cross-functional stakeholders to ensure timely availability of submission materials • Plan promotional submissions, product launches, and other time-sensitive regulatory submissions • Support workload planning and resource forecasting • Evaluate and improve operational processes, including standardization and automation opportunities • Establish and maintain business continuity and cross-training processes • Contribute to technology enhancements, automation, and system integration opportunities • Develop, maintain, and analyze operational metrics, dashboards, and reports • Provide operational updates and recommendations to functional leadership • Develop and maintain procedures, work practices, operational guidance, and training materials • Provide training to internal stakeholders • Assess changes to FDA promotional submission requirements and update processes and procedures • Serve as primary operational point of contact for FDA promotional submission activities • Support inspection, audit, and internal assessment readiness • Coordinate and guide Regulatory Operations personnel and supporting resources • Perform other regulatory, operations, legal, and/or corporate duties as requested

🎯 Requirements

• 5+ years of relevant experience in pharmaceutical regulatory operations, including FDA promotional submissions and Form FDA 2253 requirements • Knowledge of FDA promotional submission requirements and applicable OPDP presubmission processes • Ability to independently manage complex operational activities, competing priorities, and time-sensitive deliverables • Experience evaluating operational processes, identifying improvement opportunities, and implementing effective solutions • Experience with regulatory submissions systems, document management platforms, workflow technologies, and related operational tools • Strong analytical and problem-solving skills, including developing and interpreting operational metrics, dashboards, and reporting • Strong project management, organizational, and cross-functional coordination skills • Independent judgment, proactive communication, and ability to develop actionable recommendations • Ability to lead projects, coordinate resources, and provide guidance or oversight to others • Strong written and verbal communication skills, including communication with senior stakeholders • Active Notary Public commission in the applicable jurisdiction, or ability to obtain a commission within six months of appointment; must maintain a valid commission thereafter • Bachelor's degree in a relevant discipline preferred, or equivalent combination of education, training, and relevant professional experience • Additional training or certification in regulatory affairs, regulatory operations, project management, or related disciplines preferred • Paralegal certification and notary public commission preferred • Ability to type/keyboard, stand, and lift/carry/pull light items (10 lbs.) • Ability to use a computer, phone, and copier

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits • Occasional travel may be required

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