Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our programs are focused on cholestatic liver diseases in children and adults. Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, improving pruritus and long-term outcomes. Our goal is to give patients and families their lives back.
The Director, Regulatory Affairs provides management of all aspects of regulatory affairs related to the development of novel liver drugs including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
- Develops the global regulatory strategy for the assigned program, in conjunction with and under the leadership of the Head of Regulatory Affairs.
- For the development product, prepares and directs the regulatory documentation to support clinical trial applications, INDs, and amendments, as required, in accordance with regulations, guidance and legal obligations.
- Interaction with the Regulatory, Clinical Research, Clinical Operations and other functions to ensure optimal execution of the agreed regulatory strategy for development medicinal products.
- Manages interactions with Regulatory consultants and contract research organizations, as needed.
- Represents the Regulatory Affairs function at cross functional submission and study management team meetings.
- Responsible for maintaining strong knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams.
- Work with technical and medical writing to direct and submit product prioritization designation requests, e.g. orphan drug, rare pediatric designation, breakthrough therapy, fast track, accelerated approval, PRIME, etc., in US and EU, respectively
- Works with appropriate internal team members to direct and submit initial PIP applications and modifications, as needed.
- Work with medical writing and clinical operations to support and ensure timely safety reporting to regulatory agencies.
- Work with technical and medical writing to direct document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables.
- Work collaboratively with the Director, CMC Regulatory Affairs to direct preparation of CMC documentation, as needed, per regulatory requirements.
- Maintain archive and tracking of ongoing submissions.
- Work directly with the electronic publisher to get submissions published.
- Supports the Head 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 15 years in the pharmaceutical industry or relevant work experience and a minimum of 10 years in Regulatory Affairs.
- 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 experience 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.
- This is a high growth, fast paced small organization. The ability to be productive and successful in this type of work environment is critical.
- Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 5% of work time.
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