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Salary: USD 280,000 - 310,000 / annual
Mirum Pharmaceuticals, a biopharmaceutical company focused on rare disease treatments, seeks a Senior Director of Global Regulatory Affairs to provide strategic regulatory leadership across multiple clinical development programs in assigned therapeutic areas.
In this role, you will serve as the Global Regulatory Therapeutic Area Lead, responsible for ensuring global regulatory compliance and overseeing timely delivery of submissions and approvals for regulatory procedures including IND, NDA, MAA, and life cycle management activities across multiple projects. You will develop and oversee global regulatory strategy in conjunction with the SVP of Global Regulatory Affairs, lead Global Regulatory Project Team meetings, and represent the regulatory function across Program Teams including Clinical Development, Clinical Operations, Biometrics, Nonclinical Science, Drug Safety and Pharmacovigilance, and Quality Assurance.
Key responsibilities include: overseeing preparation of regulatory documentation and briefing books for Health Authority interactions; leading critical review of submission documents for regulatory compliance; contributing to and reviewing responses to global Health Authority questions; providing global regulatory advice throughout the product life cycle; overseeing development of submission content and format for international variations and amendments; actively participating in Health Authority meetings; articulating regulatory challenges and risks with recommended solutions to Program Teams and Senior Management; maintaining working knowledge of regulatory requirements and communicating changes to teams; and managing direct reports with mentorship to junior professionals.
The role requires on-site presence at headquarters minimum 2 days per week, with 10-15% domestic and international travel anticipated.
QUALIFICATIONS:
- Bachelor's or Master's degree in biological or life sciences, related scientific discipline, pharmacy, or medicine (advanced degree desirable)
- Minimum 15 years in pharmaceutical industry with minimum 12 years in Global Regulatory Affairs
- Mandatory experience with major Health Authorities: US FDA, Health Canada, and EMA
- Strong understanding of US FDA, EU, and international pharmaceutical guidance, regulations, drug development processes, and industry standard practices
- Highly preferred: experience with major regulatory submissions (NDA/NDS/MAA, Pediatric Investigation Plans, Orphan Drug Designation activities)
- Highly preferred: experience in all phases of development and post-marketing activities
- Demonstrated ability to analyze and interpret efficacy and safety data
- Strong understanding of regulatory operational activities
- Outstanding people management skills required
- Outstanding interpersonal and communication skills
- Required: experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on regulatory strategy
- Demonstrated proficiency in organizational awareness and cross-functional collaboration on global teams
- Excellent planning and organizational skills with ability to manage multiple projects simultaneously with tight timelines
- Ability to work under minimal supervision
- Willingness and ability to travel domestically and internationally
