Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults. Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.
The Senior Director, Regulatory Affairs provides leadership for and management of key aspects of regulatory affairs related to the development of novel liver drugs. Specifically, this position focuses on clinical/nonclinical regulatory strategy lead for our two programs in all phases of development. The individual must possess a thorough knowledge of global rules, regulations, and guidances governing drugs in all phases of development and in pediatrics. Strong communication, leadership and management skills are required.
- Drives the development of the global regulatory strategy along with the VP, Regulatory for all programs.
- Oversees and influences a team of regulatory employees and product teams to maximize the likelihood of regulatory success.
- Provide strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with ICH requirements, regional requirements and scientific and company policies and procedures.
- Prepare, deliver and/or manage submissions that are technically complex, high quality and requires extensive interaction with departments outside of regulatory affairs that meets corporate and program milestones, including IND to NDA/MAA.
- Directs the preparation and management of product prioritization designation requests, e.g., orphan drug, rare pediatric designation, breakthrough designation, fast track, accelerated approval, PRIME, etc. in US and EU.
- Works with appropriate internal team members to direct and submit initial PIP applications and modifications, as needed.
- Provide critical review of documents related to clinical and nonclinical to ensure messaging is consistent with program strategy.
- Strategically plan, lead, prepare for, and execute meetings and teleconferences with regulatory agencies.
- Maintain knowledge of and monitor changes in current global rules, regulations, and guidance governing drugs in all phases of development, as well as knowledge of therapeutic area(s).
- Mentor and provide guidance to direct reports on formulating regulatory strategies and working effectively in cross-functional teams.
- Provide management support to direct reports to help further their career development.
- Work collaboratively with the Director, CMC Regulatory Affairs to direct preparation of quality documentation, as needed, per regulatory.
- Oversee maintenance of archival and tracking of ongoing submissions.
- Supports the VP of Regulatory Affairs as required.
- Degree in biological or life sciences, pharmacy, or medicine (or international equivalent). An advanced degree is desirable with a minimum of 12+ years in the pharmaceutical industry or relevant work experience and a minimum of 8 years in Regulatory Affairs.
- Must have experience with pediatric drug development.
- Experience in the preparation and submission of regulatory documentation to support Agency review/approval procedures, post approval activities, and a good breadth of understanding of US and EU regulations (International is a plus).
- Experience representing Regulatory Affairs on cross-functional teams is desirable.
- Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
- Excellent communication skills both in writing and verbally.
Knowledge, Skills and Abilities:
- Ability to work under minimal supervision, but able to follow detailed instruction with well-defined procedures. Resilient profile with the ability to deliver in an ambiguous environment.
- Ability to engage and manage multiple stakeholders to achieve the business objective.
- Curious with learning agility.
- Operationally excellent.
- Organized with systematic approach to prioritization.
- Process orientated to achieve the business objective.
To apply, please send your resume to firstname.lastname@example.org.