Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare liver diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare liver diseases. 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.
The Associate 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 Regulatory Line Management.
For the development product, prepares and/or manages the regulatory documentation to support clinical trial applications, INDs and amendments, expanded access programs, as required, in accordance with regulations, guidance and legal obligations.
Interacts 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 a strong knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams.
Works with technical and medical writing to manage and submit product prioritization designation requests, e.g. orphan drug designation, rare pediatric designation, breakthrough therapy, fast track, accelerated approval, PRIME, etc., in the US and EU
Works with appropriate internal team members to direct and submit initial PIP applications and modifications, as needed.
Responsible for preparing and leading interactions with Regulatory Agencies.
Works with medical writing and clinical operations to manage and ensure timely safety reporting to regulatory agencies.
Works with technical and medical writing to manage document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables.
Works collaboratively with the CMC Regulatory Affairs to manage preparation of CMC documentation, as needed, per regulatory requirements.
Maintain archive and tracking of ongoing submissions and communications.
Work directly with the electronic publisher to get submissions published.
Supports the Regulatory Line Management 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.
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 in providing regulatory leadership and strategy for development of rare pediatric disease program.
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.
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 a work environment is critical.
Willingness and ability to travel is required, it is anticipated that this will be 5% of work time.
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.
Mirum Pharmaceuticals is also committed to the safety and wellbeing of all who work with us. As we continue to monitor the COVID-19 pandemic, Mirum Pharmaceuticals has made the decision to require all perspective candidates and independent contractors in the United States to be fully vaccinated against the COVID-19 virus. To be considered fully vaccinated is to have both doses of a two-dose vaccine two weeks apart or two weeks since a single-dose vaccine has been administered. This does not apply to candidates/independent contractors who are granted an accommodation/exemption by Mirum Pharmaceuticals based on qualifying religious or medical reasons.
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.