Remote Senior Director, Global Regulatory Strategy

BioSpace; United States; On-site; USD 242,000 - 313,000; Full time

Benefits offered by this job

Discretionary annual bonus

Long-term incentive equity

Flexible work arrangements / hybrid

Job summary

Beeline Medicines seeks a Senior Director, Regulatory Strategy – Global Regulatory Lead to drive regulatory planning and execution for immunology/inflammation programs. You will shape filing strategies across major markets and guide development teams on regulatory expectations.

The role requires 12+ years in regulatory affairs, with demonstrated leadership in global strategy, agency meetings, and cross-functional collaboration.

Qualifications

• Advanced degree in life sciences (PhD, PharmD, or master’s) required.
• 12+ years in regulatory affairs with global leadership in clinical development.
• Strong knowledge of FDA/EMA regulations and global regulatory strategy.

Responsibilities

• Lead integrated global regulatory strategies for I&I programs across FDA, EMA, and other jurisdictions.
• Manage Health Authority interactions, including meetings and briefing documents.
• Develop and maintain iRDPs and regulatory timelines aligned with clinical plans.
• Lead IND, CTA, NDA/BLA submissions and pediatric development plans.

Skills

Regulatory strategy

FDA/EMA expertise

Leadership

Agency meetings

Cross-functional collaboration

Education

Advanced life sciences degree

Job description

Beeline Medicines seeks a Senior Director, Regulatory Strategy – Global Regulatory Lead to drive regulatory planning and execution for immunology/inflammation programs. You will shape filing strategies across major markets and guide development teams on regulatory expectations.

The role requires 12+ years in regulatory affairs, with demonstrated leadership in global strategy, agency meetings, and cross-functional collaboration.