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European Union Regulatory Affairs, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
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 Director, CMC Regulatory Affairs 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 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.
Internal Number: HRR2021
About Mirum Pharmaceuticals
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.