Director, Global Regulatory Lead

Role Summary

Director, Global Regulatory Lead. Responsible for leading global regulatory strategy and representation for assigned biologic programs, with visibility to development teams and executive leadership.

Responsibilities

• Lead the company‚Äôs global regulatory strategy for select Disc investigational programs, drawing from experience and creative, reasoned thinking to maximize opportunities and mitigate risks.
• Act as a primary regulatory representative for assigned Disc Medicine programs.
• Represent the company in communications and meetings with health authorities, assess new regulations' impact, manage regulatory documents, etc.
• Have and maintain in-depth knowledge and understanding of applicable US/EU regulations on development for biologic products.
• Lead regulatory submissions to ensure phase-appropriate and compliant RA applications are submitted globally.
• Ensure Disc‚Äôs compliance with regulatory requirements and Disc Medicine's internal Standard Operating Procedures (SOPs).
• Author, review, and/or approve documentation, regulatory strategies, and regulatory content for applicable submissions/programs.
• Provide appropriate regulatory oversight of Disc Medicine programs.
• Ensure regulatory conformance and consistency with internal procedures and high scientific standards for quality, assessing best practices for improvements in the current process(es).
• Collaborate with internal and external Disc Medicine stakeholders to make science-driven, phase-appropriate, and risk-based decisions, proactively identify gaps and design mitigation strategies for development.
• Interact effectively with functional leads such as nonclinical, clinical, and other stakeholders across Disc Medicine. Participate in program teams supporting the RA function, liaise with third parties representing RA, and be responsible for the notification and inclusion of the most appropriate individuals within the company to address priority issues.
• Anticipate new or changing regulations on development and coordinate with internal stakeholders to develop strategies to address any potential changes.

Qualifications

• BA/BS required, Ph.D. or other graduate degree preferred.
• A minimum of 12-15 years regulatory experience and 12 years of total pharmaceutical/related industry experience.
• Experience interacting with applicable health authorities.
• Thorough knowledge of FDA, EMA, PMDA, regulations and experience with other regulators internationally is a plus.
• Familiarity with ICH guidelines regarding oversight of development programs.
• Experience in aspects of development during different phases of clinical development (Pre-Clinical, IND, Phase 1, Phase 2, Phase 3, and NDA/BLA/MAA).
• Experience working on project teams. The candidate should be a self-driven individual with organizational skills, building working relationships, and communication skills.
• Experience developing business processes, procedures, and/or templates to guide RA development.

Salary

Salary Range: $192,950 - $261,050 USD