Global Regulatory Strategy Director

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 180,000 - 240,000; Full time

Job summary

Otsuka ICU Medical LLC in Austin, TX seeks a senior Regulatory Affairs leader to steer global regulatory strategies for drug products and devices, secure INDs/NDAs/510(k) approvals, and maintain registrations across markets. The role requires 10+ years in pharmaceutical regulatory affairs, 5+ years in management, and direct FDA/Health Canada experience.

You will direct submissions, mentor staff, and represent the company in regulatory interactions.

Qualifications

• Bachelor's degree (STEM) required; advanced degree preferred (PhD, PharmD, MD, or MS).
• 10+ years in pharmaceutical regulatory affairs with a track record in regulatory submissions.
• 5+ years of management experience in regulatory affairs, global regulatory experience preferred.

Responsibilities

• Develops and implements global regulatory strategies for development projects and manufacturing improvements.
• Leads preparation of registration packages and responses to deficiency letters for timely submissions.
• Acts as primary liaison for regulatory agency interactions (FDA, Health Canada) and prepares briefing materials for meetings.
• Mentors staff, aligns goals with business partners, and manages resource allocation for regulatory programs.
• Keeps abreast of global regulatory changes and leads implementation across programs.

Skills

Regulatory strategy

Leadership

Regulatory submissions

Negotiation

Cross-functional collaboration

Education

Bachelor's degree in STEM

Advanced degree preferred (PhD/MD/PharmD/MS)

Job description

Otsuka ICU Medical LLC in Austin, TX seeks a senior Regulatory Affairs leader to steer global regulatory strategies for drug products and devices, secure INDs/NDAs/510(k) approvals, and maintain registrations across markets. The role requires 10+ years in pharmaceutical regulatory affairs, 5+ years in management, and direct FDA/Health Canada experience.

You will direct submissions, mentor staff, and represent the company in regulatory interactions.