Director, Global Regulatory Lead

Role Summary

Director, Global Regulatory Lead is a hybrid role supporting a fast-growing portfolio. The primary regulatory representative for assigned biologic program(s) with visibility to development teams and executive leadership.

Responsibilities

• Lead the company's global regulatory strategy for select investigational programs to maximize opportunities and mitigate risks.
• Act as the primary regulatory representative for assigned Disc Medicine programs.
• Represent the company in communications and meetings with health authorities; assess regulatory impact and manage regulatory documents.
• Maintain in-depth knowledge of applicable US/EU regulations for biologic development.
• Lead regulatory submissions to ensure phase-appropriate and compliant RA applications are submitted globally.
• Ensure regulatory compliance with applicable requirements and internal SOPs.
• Author, review, and/or approve regulatory documentation, strategies, and content for submissions/programs.
• Provide regulatory oversight of Disc Medicine programs.
• Ensure conformance with internal procedures and high scientific standards; identify and implement process improvements.
• Collaborate with internal and external stakeholders to make science-driven, risk-based decisions; identify gaps and design mitigation strategies.
• Interact with functional leads across Disc Medicine; participate in RA program teams; liaise with third parties; coordinate appropriate involvement for priority issues.
• Anticipate regulatory changes and coordinate strategies with internal stakeholders to address potential changes.

Qualifications

• BA/BS required; Ph.D. or other graduate degree preferred.
• 12‚Äì15 years regulatory experience and ~12 years total pharmaceutical/related industry experience.
• Experience interacting with health authorities.
• Thorough knowledge of FDA, EMA, PMDA regulations; experience with other regulators is a plus.
• Familiarity with ICH guidelines for development oversight.
• Experience across Phases of clinical development (Pre-Clinical, IND, Phase 1‚Äì3, NDA/BLA/MAA).
• Experience working on project teams; strong organizational, relationship-building, and communication skills.
• Experience developing business processes, procedures, and templates to guide RA development.

Skills

• Regulatory strategy development
• Regulatory submissions and document management
• Health authority communications
• Cross-functional collaboration
• Critical thinking and risk management

Education

• BA/BS required; advanced degree preferred.

Additional Requirements

• Location: hybrid role with remote work and Watertown, MA headquarters.