Manager, Regulatory Compliance

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $121.1k - $181.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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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

• Provide critical support for regulatory compliance activities from planning through execution • Support SOP maintenance and GxP compliance • Support GRA inspection and audit readiness and management activities • Own regulatory impact assessment compliance and tracking • Coordinate GRA-related controlled document revision cycles and ad-hoc revisions • Work with the GSOP office to schedule KOMs, manage timelines, follow up, and support stakeholders • Maintain knowledge and access to GSOP systems including Veeva Vault and Monday.com • Maintain the GRA SOP revision tracker and participate in quarterly GSOP engagement meetings • Act as GRA representative for DEAL reviews • Lead inspection readiness activities, including inspection calendar management, functional-area presentations, KOM scheduling, notifications, document requests, audit-report review, CAPA and deviation tracking • Collaborate with Regulatory Intelligence and Pharmacovigilance on annual RRS updates • Participate in review and qualification of PV dashboard curated inbox notifications • Develop and implement newsletters and compliance communications strategies • Coordinate monthly regulatory milestone report updates with Regulatory Strategy • Coordinate and facilitate GRA meetings and departmental events • Maintain the GRA Collaboration Portal, contact lists, Outlook distribution lists, and organizational charts • Analyze compliance metrics and trends, provide KPI recommendations and monthly reports, and drive corrective actions • Prepare and maintain compliance work instructions and onboarding/offboarding materials • Support cross-functional meetings through project reports, presentations, agendas, minutes, outcome tracking, and deliverable follow-up • Ensure plans and activities meet timelines and escalate challenges or deviations • Create, administer, and summarize surveys as needed

🎯 Requirements

• Bachelor's degree in life sciences, scientific, or engineering field • 4+ years of general regulatory affairs experience • Knowledge of the drug development process • 3 years of audit and inspection experience • Prior experience working in the pharmaceutical and/or healthcare industry (preferred) • Prior experience with new prescription drug/biologic applications, including IND and/or NDA/BLA (preferred) • Strong oral and written communication skills • Working knowledge of the drug development process, laws, regulations, and guidelines including FDA and ICH • Excellent organizational skills and ability to learn and grow • Ability to manage and communicate issues, scopes, progress, and risks throughout the project lifecycle • Ability to prioritize, multitask, problem solve, and work in a fast-paced environment • Ability to establish working relationships with cross-functional teams • Strong experience with Microsoft Word, Excel, PowerPoint, and Outlook • Familiarity with electronic document management systems (EDMS) • Ability to offer innovative problem-solving solutions

🏖️ Benefits

• Incentive opportunity • 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

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