Senior Manager, Global Regulatory Strategy

Otsuka America Pharmaceutical Inc.; Madison (WI); Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking an experienced Regulatory Affairs professional to support global regulatory strategy, planning and execution of global submissions (IND, CTA, NDA/MAA) and lifecycle activities for assigned projects in line with the Global Regulatory Lead.

You will translate complex global requirements, collaborate with GRL and cross‑functional teams, prepare submissions, manage health authority interactions, and guide project teams to achieve timely approvals.

Qualifications

• Experience working in the pharmaceutical and/or healthcare industry.
• Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).
• RAC certification a plus.

Responsibilities

• Supports global regulatory strategy, planning and execution of global submissions aligned with the Global Regulatory Lead.
• Identifies regulatory intelligence and assesses regulatory options for products.
• Translates global requirements and communicates regulatory challenges to GRL and teams.
• Collaborates with GRL and cross‑functional teams to develop regulatory plans and address health authority queries.
• Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities (INDs, amendments, NDA/CTA, etc.).
• Manages preparation of INDs, CTAs, amendments, and reports within timelines and guidelines.
• Ensures submission documents are accurate and high quality for approvals.
• Serves as sponsor contact to health authorities and guides project teams with regulatory guidance.
• Manages internal/external staff and consultants for assigned projects.
• Interacts with internal/external units to gather data and documentation for submissions.
• Executes departmental initiatives to improve efficiency and quality.
• Develops innovative ideas to address challenges in GRA.

Skills

Regulatory affairs

IND/CTAs/NDAs

FDA/ICH knowledge

Communication skills

Regulatory intelligence

Team leadership

Cross-functional collaboration

EDMS & MS Office

Education

Bachelor's degree in life sciences/regulatory

Master's degree in regulatory affairs

Tools

EDMS

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. is seeking an experienced Regulatory Affairs professional to support global regulatory strategy, planning and execution of global submissions (IND, CTA, NDA/MAA) and lifecycle activities for assigned projects in line with the Global Regulatory Lead.

You will translate complex global requirements, collaborate with GRL and cross‑functional teams, prepare submissions, manage health authority interactions, and guide project teams to achieve timely approvals.