Director, Regulatory Project Manager

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

Position Summary

We are seeking a Director-level Regulatory Project Manager (RPM) to lead global regulatory project management efforts across key development programs. This high-impact role is responsible for orchestrating the planning, tracking, and execution of complex regulatory submissions (e.g., INDs/CTAs, NDAs/BLAs, MAAs), aligning with program strategies, regulatory frameworks, and organizational priorities.

The RPM will partner closely with Regulatory Leads, cross-functional stakeholders (e.g., Clinical, CMC, Nonclinical, Safety, Labeling), external vendors, and senior leadership to ensure regulatory milestones are achieved with excellence. This position offers a unique opportunity to drive regulatory execution within a mission-driven and fast-paced biotech environment.

Key Responsibilities

• Serve as the regulatory project lead for one or more development programs, coordinating global submission planning and operational readiness.
• Develop and maintain comprehensive project plans and timelines for major regulatory submissions (INDs, CTAs, NDAs, BLAs, MAAs, sNDAs).
• Track and manage submission deliverables, risk mitigation strategies, and milestone reporting.
• Coordinate and facilitate Regulatory Subteam meetings: define agendas, track action items, and follow through on key decisions.
• Drive cross-functional alignment with CMC, Clinical, Safety, Nonclinical, and Labeling teams on regulatory objectives.
• Support Regulatory Leads in preparation for Health Authority meetings, including briefing book development, logistics, and commitment tracking.
• Oversee submission readiness activities, including document QC, publishing coordination, and vendor oversight.
• Maintain and communicate real-time dashboards and status updates to leadership.
• Collaborate with Program Management team to ensure synchronization between regulatory and broader development plans.
• Drive continuous process improvements within Regulatory PM tools, systems, and workflows.
• Mentor project management team members and contribute to capability-building across the function.

Qualifications

• Bachelor's degree in a life science or related field required; advanced degree (MS, PharmD, PhD) preferred.
• 12- 15+ years of experience in the biotech/pharma industry, including 7+ years in regulatory affairs or regulatory project management.
• Demonstrated success leading global regulatory submissions, including INDs, NDAs, BLAs, MAAs, and CTAs.
• In-depth knowledge of FDA, EMA, ICH, and other major regulatory guidelines.
• Proficient with tools such as Veeva Vault RIM, eCTD publishing platforms, SmartSheet, OnePager, and MS Project.
• Exceptional organizational and project management skills, with a proven ability to manage complex, fast-paced workflows.
• Strong interpersonal and influencing skills across matrixed environments and all levels of the organization.
• Excellent verbal and written communication, including experience communicating with executive stakeholders.
• PMP certification a plus but not required.
• Willingness to travel occasionally (<10%), including potential international meetings.

Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been