Senior Director, Regulatory Affairs — Global Submissions Lead

Omeros Corporation; United States; On-site; USD 195,000 - 260,000; Full time

Job summary

Omeros Corporation in the United States seeks a Director or Senior Director, Regulatory Affairs to provide regulatory leadership across multiple development programs and lifecycle contributions for clinical and commercial initiatives.

The role requires strategic oversight, collaboration with cross-functional teams, and direct interface with regulatory authorities, ensuring timely and compliant submissions and program advancement.

Qualifications

• BS degree required with 10+ years in pharma for Director level; 14+ for Senior Director.
• RAC certification a plus; experience developing regulatory strategies.

Responsibilities

• Advise on global and national regulatory requirements for development programs.
• Provide leadership and supervision to staff in regulatory plans and strategies across early development to post-commercialization.
• Develop regulatory strategies with cross-functional teams and lead key submissions.

Skills

Regulatory strategy leadership

Strong written and verbalCommunication

Leadership and supervision

Excellent teamwork

Analytical problem-solving

Education

BS degree

RAC Certification (plus)

Job description

Omeros Corporation in the United States seeks a Director or Senior Director, Regulatory Affairs to provide regulatory leadership across multiple development programs and lifecycle contributions for clinical and commercial initiatives.

The role requires strategic oversight, collaboration with cross-functional teams, and direct interface with regulatory authorities, ensuring timely and compliant submissions and program advancement.