Director, Global Regulatory Lead

Role Summary

Director, Global Regulatory Lead. Responsible for leading global regulatory strategy and acting as the primary regulatory representative for assigned biologic programs within Disc Medicine’s pipeline. Reports to the Vice President of Global Regulatory Affairs.

Responsibilities

• Lead the company‚Äôs global regulatory strategy for select Disc investigational programs, maximizing opportunities and mitigating risks.
• Act as the primary regulatory representative for assigned Disc Medicine programs.
• Represent the company in communications and meetings with health authorities, assess regulatory impacts, and manage regulatory documents.
• Maintain in-depth knowledge of applicable US/EU regulations on biologic product development.
• Lead regulatory submissions to ensure phase-appropriate and compliant RA applications are submitted globally.
• Ensure regulatory compliance with regulatory requirements and internal SOPs.
• Author, review, and/or approve documentation, regulatory strategies, and regulatory content for submissions/programs.
• Provide regulatory oversight of Disc Medicine programs and ensure conformance with internal procedures and high scientific standards.
• Collaborate with internal and external stakeholders to make science-driven, phase-appropriate, risk-based decisions; identify gaps and design mitigation strategies.
• Interact effectively with functional leads across Disc Medicine; participate in RA program teams; liaise with third parties representing RA.
• Anticipate new or changing regulations 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 applicable 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 clinical development phases (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.

Salary

• $192,950 - $261,050 USD