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.
Located in our Basel office, the Associate Director, EU Regulatory Affairs provides EU support pertaining to all aspects of regulatory affairs related to the development of novel liver drugs including quality, pre-clinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
- Works with the product leads, prepare regulatory documentation, as required, in accordance with regulations, guidance and legal obligations.
- Prepares and coordinates the regulatory documentation to support clinical trial applications and amendments, in the European Union.
- 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 EU Regulatory Affairs function at cross functional submission and study management team meetings.
- Responsible for maintaining a working knowledge of EU 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, PRIME, etc., in EU.
- Work with medical writing and clinical operations to manage DSURs 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/IMPD documentation, as needed, per EU requirements.
- Maintain archive and tracking of ongoing CTAs submissions, EMA communication and related issues to resolution.
- Work directly with the electronic publisher to get submissions published.
- Ensure the licensed product packaging and associated information is updated and maintained in accordance with Marketing Authorization including the review and management of labelling translations and artwork.
- Supports the Head of Regulatory Affairs as required.
- Bachelor’s 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 EU Regulatory Affairs.
- Experience in the preparation and submission of regulatory documentation to support centralized MAA procedure and post approval activities and a good breadth of understanding of the European regulations.
- Knowledge and experience relating to clinical trials would also be desirable.
- Experience representing Regulatory Affairs on cross functional teams is desirable.
- Excellent planning and organizational skills and the ability to work simultaneously on a number of projects with tight timelines.
- Excellent communication skills both in writing and verbally.
- Ability to work under minimal supervision but able to follow detailed instruction with well-defined procedures.
KNOWLEDGE, SKILLS & ABILITIES
- 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 a work environment is critical.
Please submit your resume to firstname.lastname@example.org