Director, Regulatory Project Management

Regulatory Toolkit; Foster City (CA); Híbrido; USD 230.000 - 250.000; Jornada completa

Descripción de la vacante

Mirum Pharmaceuticals is seeking a Director of Regulatory Project Management to lead planning and execution for Regulatory Medical Writing. You will guide timelines, risks, and cross-functional collaboration to support high-quality regulatory submissions (NDAs, MAAs, INDs) and lifecycle filings.

The role requires senior-level leadership, strong communication, and the ability to influence across functions and with senior stakeholders. Hybrid work options are available.

Formación

• Bachelor’s degree in biological or life sciences or related discipline. An advanced degree is desirable.
• 10+ years in the pharmaceutical industry with a deep understanding of drug development.
• Prior project management experience with NDA/MAA/Lifecycle submissions and review is required.

Responsabilidades

• Partner across the RMW department and cross-functional teams to ensure timelines and strategies are executed.
• Co-lead Global Regulatory Project Team (GRPT) meetings with GRL.
• Develop and manage integrated submission project plans across Modules 1-5.
• Identify regulatory and project risks and propose solutions to leadership.
• Prepare agendas, minutes, decisions and risk mitigation plans; centralize team information.
• Organize reports and trackers to communicate status and updates.

Conocimientos

Project leadership

Stakeholder influence

Strong communication

Independent work

Mentoring

Educación

Bachelor in life sciences

Advanced degree desirable

Herramientas

MS Project

SharePoint

Veeva

Descripción del empleo

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

POSITION SUMMARY

The Director, Regulatory Project Management provides strategic leadership and oversight for the planning and execution for Regulatory Medical Writing (RMW) Department deliverables, including, high-quality regulatory submissions of original applications (i.e., NDAs, MAAs, INDs, etc.), rare disease designations, major supplements/variations, and lifecycle submissions for assigned programs. This position will contribute to regulatory submission strategy, working in close collaboration with the RMW team, Global Regulatory Lead (GRL), as well as cross-functional teams to identify submission risks and opportunities, define regulatory deliverables, and build timelines/dashboards to support regulatory filings through licensure and beyond.

The Director also serves as a senior advisor to leadership, guiding decision-making, resource planning, and continuous improvement of RMW processes.

JOB FUNCTIONS/RESPONSIBILITIES

• Responsible for partnering across the RMW Department (Strategic Regulatory, CMC Regulatory, Labeling, Ad-Promo, Regulatory Information Management, and Medical Writing) and with cross-functional project teams to ensure regulatory timelines/strategies are developed and seamlessly executed upon, enabling successful filings with Global Health Authorities.
• Co-lead Global Regulatory Project Team (GRPT) meetings in partnership with GRL.
• Co-lead product/submission-specific multi-disciplinary Filing Teams – working with all major contributors to set expectations and ensure timelines are met.
• Develop/actively manage project timelines and integrated submission project plans to ensure timelines remain on schedule.
• Work with each function to understand individual deliverables and interdependencies between deliverables to create and maintain an overall project plan timeline across all Modules (Modules 1-5).
• Identify and communicate both regulatory and project risks – providing potential solutions to the cross-functional project team and leadership as needed.
• Prepare meeting agendas, meeting minutes and document decisions/action items/risk mitigation plans. Organize and maintain this team information in a central location.
• Prepare and distribute reports/trackers to communicate updates and project status.
• Proactively drive project/submission teams and establish an appropriate level of urgency with a keen focus on deliverables.
• Conduct lessons learned sessions to identify areas for improvement.
• Standardize processes/dashboards to manage overall, cross-portfolio RMW submission workload.
• Track overview of major submission and health authority activity to aid in Regulatory resource planning.
• Organize key aspects of the regular RMW Department on site activities as needed.
• Support the Head of Regulatory Project Management & Information Systems as required.

QUALIFICATIONS

Education /Experience:

• Bachelor’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent). An advanced degree is desirable.
• 10+ years in the pharmaceutical industry with a deep understanding of drug development.
• Prior project management experience with NDA/MAA/Lifecycle submissions and review is required.

Knowledge, Skills and Abilities:

• Expert in project management with advanced expertise using related software and tools (e.g. MS Project, Sharepoint, Veeva, etc).
• Demonstrated experience in leading decision-making within cross-functional teams.
• Excellent organizational and communication skills, both written and verbal.
• Ability to work independently, influence senior stakeholders, set strategic project direction, and manage ambiguity.
• Proactive, collaborative, and solution-oriented with strong organizational discipline.
• Strong interpersonal skills and the ability to lead, mentor, and develop regulatory project managers/other junior staff as needed.

The salary range for this position is $230,000 to $250,000USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

#LI-HYBRID

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.