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.
The Senior Director/Director, Head of EU Regulatory Affairs provides leadership pertaining to all aspects of regulatory affairs related to the development and commercialization of novel liver drugs including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations in the EU and UK. This position will drive and implement EU and UK regulatory strategies and timely delivery of marketing applications with optimal product labeling in these regional markets (in collaboration with the Senior Director, Regulatory Commercial and Labeling). The role is responsible for building and maintaining excellent working relationships with EMA coordinators and national competent Health Authorities (HAs) in the EU, ensuring full regional regulatory compliance, and overseeing submissions and approvals of dossiers supporting the company’s portfolio in the EU and UK. This role facilitates collaboration between colleagues in the West Coast, East Coast, and Switzerland and will be a member of the RA Leadership Team, a member on project teams in R&D (as needed), and act as the primary RA contact for the company’s EU Regulatory vendor and for Health Agencies in EU and UK.
- In collaboration with Regulatory project leads and Regulatory CMC, designs strategic vision for the Regulatory Affairs function in the EU and UK and ensures its successful execution by the respective project teams.
- Represents Regulatory on the commercial and development project teams (as needed) when pertinent regulatory deliverables in the EU and the UK are discussed and is accountable for the effective management of the associated regional regulatory activities in the EU and UK.
- Advises project teams regarding the development and implementation of regulatory strategy through the CMC, clinical, and nonclinical development processes in the EU and the UK.
- Support Commercial function in the designs of the EU/UK regional brand strategy for local brands in Europe and in the UK.
- Establishes and maintains excellent relationships with EU and UK health agencies and will be the primary point of contact for these Agencies on the company’s filings.
- Shapes regulatory environment by active participation at HA meetings, when required.
- Primary point of contact to the company’s EU regulatory vendor.
- In collaboration with Regulatory project leads and Regulatory CMC, sets strategic direction on the development of content, format, and accountability for regulatory submissions and related variations and amendments in the EU and UK.
- Conducts risks and gaps assessment and identifies potential areas of regulatory concern and responds to new government/regulatory developments in the EU and UK.
- Responsible for maintaining a working knowledge of EU regulatory requirements and guidelines and for communicating changes in regulatory information to project teams.
- Create and support policies and Standard Operating Procedures for processes related to EU/UK submissions.
- In collaboration with the Head of Regulatory Commercial and Labeling, provides the EU/UK perspective to labeling aspects for the Target Label Profile and the Company Core Data Sheet.
- Supports the Head of Regulatory Affairs as required.
- Bachelor’s or Master’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent); An advanced degree is desirable.
- A minimum of 12 years in the pharmaceutical industry with a minimum of 9 years in EU Regulatory Affairs.
- Fluency in English as a business language; additional language is an asset.
- Significant experience in a leadership role with MAA submissions and approvals.
- Experience in a leadership role with HA negotiations in multiple regions.
- Experience with brand optimization strategies and commercial awareness.
- Demonstrated ability to analyze and interpret efficacy and safety data.
- Strong understanding of regulatory operational activities.
- Outstanding management, interpersonal, communication, negotiation and problem-solving skills.
- Demonstrated proficiency in organizational awareness, including experience working cross-functionally and on global teams.
- 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 10-15% of work time.
To apply, please send your resume to firstname.lastname@example.org.