POSITION SUMMARY
The position is responsible for establishing the global regulatory strategy for the company's product pipeline, providing strategic leadership, oversight, and direction for all regulatory aspects of development to ensure achievement of business objectives. As a commercial stage company, the position is also responsible for leading the team for all post-market regulatory activities globally.
JOB FUNCTIONS/RESPONSIBILITIES:
- Develops innovative global regulatory strategies aimed at gaining the earliest possible regulatory approvals in US and internationally as well as for life cycle product management.
- Provides guidance to and directs the regulatory team across regulatory specialties including clinical, CMC, advertising and promotional review, labelling, regulatory project management, operations and compliance.
- Provides expertise in translating regulatory requirements into practical and workable plans.
- For the development products, guides the regulatory team in the development of regulatory documentation to support clinical applications and marketing applications, as required, in accordance with regulations, guidance and legal obligations.
- Provides strategic input to target labeling content (SmPC, US package insert, etc.) and to product lifecycle issues.
- Leads regulatory team for submissions of product prioritization designation requests, e.g. orphan drug, rare pediatric designation, breakthrough therapy, fast track, accelerated approval, PRIME, etc., in US and EU.
- Oversees regulatory team in document preparation timelines and communication with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables.
- Leads the regulatory team who serves as point of contact and represents the Company before regulatory authorities, including the preparation of meeting agendas, materials, minutes and interpretation of regulatory correspondence.
- Interfaces or provides guidance to the regulatory team who interface with outside regulatory agencies, corporate partners and vendors to develop regulatory and registration strategies.
- Develops effective working relationships with Regulatory Agencies and participates in Agency negotiations.
- Provides expert analysis and evaluation of regulatory information for Mirum products.
- Provides leadership, direction and interpretation of FDA, EMA, and other regulatory agency guidelines to senior leadership and program teams.
- Leads department initiatives to improve standards and systems internally and maintain relationships with other departments including consultants and vendors.
- Maintains strong knowledge of global regulatory requirements and guidelines and for communicating changes or impact to the business or development programs.
- Leads the regulatory function hiring, managing, and developing personnel as needed to support Mirum development & commercial programs.
- Responsible for the regulatory department budget, including planning and spend management.
- Serves as a key member of the company leadership team, contributing to the development of product and business strategies to maximize the value of the company’s portfolio.
- Participates in potential new asset evaluation, providing strategic regulatory input and assessment of regulatory risk.
QUALIFICATIONS:
- BA/BS degree required in health and life science with 15+ years of regulatory affairs experience and 10+ years in a management role with lead regulatory responsibilities.
- Demonstrated track record of balancing strategic thinking, external engagement, and tactical execution including INDs, CTAs, NDA, and MAAs.
- Strategic, dynamic, highly collaborative, and successful senior executive with significant experience and a successful track record with global regulatory leadership in both development-stage programs and marketed products.
- Previous experience in leading a global regulatory team to prepare for major regulatory agency interactions, such as FDA pre-NDA, EOP2 meetings, scientific advice, advisory committee meetings, and/or EU oral explanations.
- Ability to influence external and internal stakeholders, including senior management, multiple internal functional departments, and his/her own organization by being a proactive, collaborative, decisive, and outstanding communicator.
- Experience in rare disease and/or pediatrics is preferred.
- Proven track record of success in building and leading high-performing teams and solid managerial experience are essential.
- Comfortable functioning in a lean biotech environment where ambiguity is common and flexibility is required.
- Possess strong leadership abilities and a strategic business perspective to bring products forward successfully.
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