Global Regulatory Strategy Manager (Remote)

Otsuka America Pharmaceutical Inc.; Little Rock (AR); Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Medical coverage

401(k) match

Paid time off

Work-life balance programs

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Regulatory Affairs professional to develop global regulatory strategy and manage submissions for INDs, CTAs, and NDA-like filings.

You will plan lifecycle activities and align with the Global Regulatory Lead (GRL) to ensure compliance. The role requires translating complex global requirements, leading teams, and collaborating with cross-functional groups to address health authority queries and regulatory obligations.

Qualifications

• Bachelor's or higher in regulatory affairs or related field with relevant experience.
• Experience preparing global regulatory submissions (IND/CTA/NDA/MAA).
• RAC certification is a plus.

Responsibilities

• Develop global regulatory strategy and planning for submissions (INDs, NDAs, etc.).
• Coordinate regulatory intelligence and precedent decisions to support options for products.
• Prepare, coordinate, review, and submit regulatory documents within timelines.

Skills

Regulatory strategy

Regulatory intelligence

Leadership

Regulatory submissions

Communication

FDA/ICH knowledge

Education

Bachelor's degree in regulatory affairs

Master's degree in regulatory affairs or related

Tools

Microsoft Office

EDMS

Job description

Otsuka America Pharmaceutical Inc. is seeking a Regulatory Affairs professional to develop global regulatory strategy and manage submissions for INDs, CTAs, and NDA-like filings.

You will plan lifecycle activities and align with the Global Regulatory Lead (GRL) to ensure compliance. The role requires translating complex global requirements, leading teams, and collaborating with cross-functional groups to address health authority queries and regulatory obligations.