Mirum Pharmaceuticals, Inc. · 2 weeks ago
Senior Director, Global Regulatory Affairs
Foster City, CA
Full-time
Hybrid
Director/Executive
$270K/yr - $285K/yr
15+ years expMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. The Senior Director, Global Regulatory Affairs will provide regulatory strategic leadership on multiple clinical development programs and ensure global regulatory compliance for submissions and approvals.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Develops and oversees the global regulatory strategy for projects in assigned TA, in conjunction with and under the leadership of the SVP, Global Regulatory Affairs
Leads the Global Regulatory Project Team meetings in collaboration with Regulatory Project Management when being the Global Regulatory Lead on a project
Oversees the preparation of regulatory documentation (meeting request/briefing books) in support of interactions with a Health Authority and provide guidance to their team
Oversees/leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements
Contributes to and reviews responses to global Health Authority questions to ensure appropriate, consistent, and complete responses, ensuring their alignment with global development strategy
Provide global regulatory advice through the product life cycle by representing the regulatory function in the Program Team when being the Global Regulatory Lead on a project
In partnership with Regulatory Project Management, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory submissions and related variations/amendments internationally in assigned TA
Actively participates in Health Authority meetings
Clearly articulate regulatory challenges/risks, identify potential solutions, and make a recommendation(s) on a path forward to Program Teams and Senior Management
Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating regulatory changes to Program Teams
Effectively manages direct report(s) and provide mentorship to junior professionals
Qualification
Required
Bachelor's or Master's degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent); an advanced degree is desirable
A minimum of 15 years in the pharmaceutical industry with a minimum of 12 years in Global Regulatory Affairs, experience with major Health Authorities (US FDA, Health Canada, and EMA) is mandatory
Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
Demonstrated ability to analyze and interpret efficacy and safety data
Strong understanding of regulatory operational activities
Outstanding people management skills are required
Outstanding interpersonal and communication skills
Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on the regulatory strategy for a given product is required
Demonstrated proficiency in organizational awareness, including experience working cross-functionally representing the Regulatory Affairs function and on global teams
Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines
Ability to work under minimal supervision
Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 10-15% of work time
On site presence at the headquarter is required (minimum 2 days a week)
Preferred
Experience with major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities) is highly preferred
Experience in all phases of development and post marketing activities is highly preferred
Company
Mirum Pharmaceuticals, Inc.
Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults.
201-500 employees
H1B Sponsorship
Mirum Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (1)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$765.5MKey Investors
TCG CrossoverOberland CapitalNew Enterprise Associates
2025-12-19Post Ipo Equity· $68.5M
2025-12-08Post Ipo Equity· $200M
2023-04-12Post Ipo Equity· $275M
Leadership Team
Joanne Quan
Chief Medical Officer
Recent News
Labiotech UG
2026-01-08
2026-01-03
2025-12-30
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