Director, Global Regulatory Lead

Role Summary

Director, Global Regulatory Lead. Hybrid role with remote work and headquarters in Watertown, MA. Primary regulatory representative for assigned biologic programs, reporting to the VP of Global Regulatory Affairs.

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 impacts 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 compliance with regulatory 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 regulatory conformance and high scientific standards; assess and implement process improvements.
• Collaborate with internal and external stakeholders to make science-driven, phase-appropriate, risk-based decisions; identify gaps and design mitigations.
• Interact with functional leads (nonclinical, clinical, and others); participate in RA program teams; liaise with third parties; ensure appropriate participants are informed.
• Anticipate regulatory changes and coordinate with internal stakeholders to address potential impacts.

Qualifications

• BA/BS required; Ph.D. or other graduate degree preferred.
• Minimum 12‚Äì15 years regulatory experience and ~12 years total pharma/related industry experience.
• Experience interacting with health authorities.
• Thorough knowledge of FDA, EMA, PMDA regulations; experience with other regulators 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; self-driven with strong organizational, relationship-building, and communication skills.
• Experience developing business processes, procedures, and templates to guide RA development.

Skills

• Regulatory strategy and submissions
• Regulatory affairs leadership
• Cross-functional collaboration
• Health authority engagement
• Regulatory documentation and content development
• Risk assessment and mitigation

Education

• BA/BS required; advanced degree preferred (Ph.D. or equivalent).

Additional Requirements

• Hybrid work arrangement; location in Watertown, MA or remote with HQ access.