Director, Global Regulatory Strategy - Biotech/Neurology

Discover International; Massachusetts; On-site; USD 180,000 - 260,000; Full time

Job summary

Discover International in the Boston area is seeking a Director-level Regulatory Lead to drive global regulatory strategy across pipeline assets and marketed products. This hands-on role blends strategy with execution, requiring leadership in cross-functional teams and interactions with regulators to translate feedback into actionable business plans.

You will guide submissions, align internal objectives with Health Authority expectations, and shape the regulatory roadmap while mentoring the

Qualifications

• 10+ years in regulatory affairs within biotech or pharma.
• Experience leading Regulatory Lead on development programs.
• Strong understanding of global regulatory requirements for neurologic assets.

Responsibilities

• Lead global regulatory strategy across pipeline and marketed products.
• Plan and deliver regulatory submissions with cross-functional teams.
• Interface with regulators and translate feedback into actionable plans.
• Represent Regulatory in governance settings and align with senior leadership.
• Share best practices across the regulatory group and mentor others.

Skills

Regulatory leadership

Cross-functional collaboration

Regulatory strategy

Drug development lifecycle

Stakeholder communication

Education

Bachelor's degree in Life Sciences

Regulatory Affairs Certification (RAC)

Tools

Veeva Vault

eCTD submission tools

Job description

Discover International in the Boston area is seeking a Director-level Regulatory Lead to drive global regulatory strategy across pipeline assets and marketed products. This hands-on role blends strategy with execution, requiring leadership in cross-functional teams and interactions with regulators to translate feedback into actionable business plans.

You will guide submissions, align internal objectives with Health Authority expectations, and shape the regulatory roadmap while mentoring the