Remote Global Regulatory Strategy Director

Angitia Bio; Northern (KY); Remote; USD 180,000 - 230,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401K with company match

Long term disability

Life Insurance & AD&D

Employee Assistance Program

Paid holidays

Vacation

Paid sick leave

Telecommunication stipend

Work-from-home equipment reimbursement

Job summary

Angitia Bio, a clinical-stage biotechnology company, seeks a Director, Global Regulatory Affairs to lead global regulatory strategies for development programs and to serve as the primary regulatory representative on cross-functional teams.

The role collaborates with Clinical Development, Nonclinical, CMC, Safety, Biostatistics, and Operations to align regulatory strategy with development and business goals.

Qualifications

• 10+ years in pharmaceutical/biotech Regulatory Affairs strategy.
• Experience supporting global development programs through registration and lifecycle management.
• Strong knowledge of US, EU, and Japan regulatory requirements.

Responsibilities

• Lead development and execution of global regulatory strategies for development programs.
• Head Global Regulatory Team and represent Regulatory Affairs on cross-functional teams.
• Provide regulatory leadership across nonclinical, clinical, CMC, and lifecycle management activities.
• Partner with cross-functional teams to shape development plans and regulatory pathways.
• Mentor junior regulatory professionals and contribute to process improvements.

Skills

Regulatory strategy

Cross-functional leadership

Global regulatory submissions

FDA/EMA/PMDA interactions

Regulatory leadership

Education

PharmD/MS/PhD/MBA or equivalent

Job description

Angitia Bio, a clinical-stage biotechnology company, seeks a Director, Global Regulatory Affairs to lead global regulatory strategies for development programs and to serve as the primary regulatory representative on cross-functional teams.

The role collaborates with Clinical Development, Nonclinical, CMC, Safety, Biostatistics, and Operations to align regulatory strategy with development and business goals.