Senior Manager, Global Regulatory Affairs

🕒 June 29

🇺🇸 United States – Remote

💵 $150k - $224.3k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 21%

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.

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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

• Support development of global regulatory strategy, planning, and execution for investigational and marketed prescription drug submissions • Manage lifecycle regulatory activities for assigned projects in alignment with the Global Regulatory Lead • Obtain regulatory intelligence and research precedent approvals and health authority decisions • Translate global requirements and assess regulatory challenges for regulatory and project teams • Collaborate with global regulatory team members to develop regulatory plans and address regulatory issues, health authority queries, and obligations • Author, coordinate, review, and execute submissions and responses to regulatory authorities • Independently manage preparation of INDs, CTAs, amendments, supplements, and aggregate reports • Confirm submission documents are accurate, compliant, and high-quality • Serve as sponsor point of contact to health authorities • Represent Global Regulatory Affairs in project team meetings and provide regulatory guidance • Manage and direct internal support staff and external consultants • Gather data and develop documentation for on-time submissions • Execute departmental initiatives to improve efficiency, quality, and output • Assess and develop innovative ideas to address current and future departmental challenges

🎯 Requirements

• Experience working in the pharmaceutical and/or healthcare industry • Knowledge and experience preparing global regulatory submissions, including IND, CTA, NDA or BLA, and MAA • Bachelor's degree with 5+ years’ experience OR Master’s degree with 2 years’ experience in regulatory affairs or related areas • Experience in regulatory affairs or related areas such as clinical development, project management, or quality assurance • Experience with FDA or other health authority interactions desirable • Strong oral and written communication skills • Working knowledge of the drug development process, laws, regulations, and guidelines, including FDA and ICH • Ability to interpret and apply regulatory intelligence • Ability to lead teams, prioritize work, proactively manage and communicate issues, and track project progress and risks • Ability to establish working relationships with cross-functional teams • Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills • Strong experience with Microsoft Office programs: Word, Excel, PowerPoint, and Outlook • Familiarity with electronic document management systems (EDMS) • RAC certification a plus • Approximately 20% travel

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death & 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 • Incentive opportunity