Director, Regulatory Project Management

Mirum Pharmaceuticals, Inc.; Foster City (CA); On-site; USD 230,000 - 250,000; Full time

Job summary

Mirum Pharmaceuticals is seeking a Director of Regulatory Project Management to lead planning and execution of Regulatory Medical Writing deliverables, including high-quality submissions for NDAs, MAAs, INDs, rare disease designations, and lifecycle filings across assigned programs.

The role partners with the GRL, regulatory team and cross-functional partners to identify risks, build timelines, and ensure timely regulatory filings through licensure and beyond, while mentoring staff and driving

Qualifications

• 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.

Responsibilities

• Lead regulatory project management across cross-functional teams to ensure timely filings.
• Co-lead Global Regulatory Project Team (GRPT) and multi-disciplinary filing teams.
• Develop and manage integrated submission plans and timelines across Modules 1-5.
• Identify regulatory and project risks, proposing solutions to leadership.
• Organize meetings, document decisions, and track project status.
• Mentor and develop junior regulatory project managers.

Skills

Project management

Cross-functional leadership

Communication

Decision making

Mentoring

Ambiguity management

Education

Bachelor's degree in biological or life sciences or related field

Advanced degree desirable

10+ years in pharma

Tools

MS Project

Sharepoint

Veeva

Job description

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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Mirum Pharmaceuticals’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.