Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our lead program is focused on two severe liver diseases in children, Alagille Syndrome and progressive familial intrahepatic cholestasis (PFIC). Both conditions can result in severe itching, liver damage and a need for liver transplant. Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage. Our goal is to give families their lives back.
The Sr. Manager/Associate Director, Regulatory Affairs provides support pertaining to 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.
- Works with the product leads, prepares regulatory documentation, as required, in accordance with regulations, guidance and legal obligations.
- For the development product prepares and/or co-ordination of the regulatory documentation to support clinical trial applications and amendments.
- 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 a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams.
- Work with technical and medical writing to manage and submit product prioritization designation requests, e.g. orphan drug, rare pediatric designation, breakthrough therapy, fast track, accelerated approval, etc., in USWork with medical writing and clinical operations to manage and ensure timely safety reporting to regulatory agencies.
- Work 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.
- Work with CMC team to manage 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 10 years in the pharmaceutical industry or relevant work experience and a minimum of 6 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 FDA regulations (EU and 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 & ABILITIES
- Ability to work under minimal supervision of Regulatory Affairs professionals, but following detailed instruction with well-defined procedures.
- Knowledge and experience relating to clinical trials would be desirable.
- 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 domestically and internationally is required, it is anticipated that this will be 5% of work time.
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