Senior Director, Regulatory Affairs - Devices and Diagnostics

Cambridge, MA /
Ultragenyx - Gene Therapy – Regulatory Affairs /
Full-time
Why Join Us?
Be a hero for our rare disease patients
 
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. 
 
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
 
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. During the COVID-19 Outbreak, we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our approach will include video discussions, interviews, and onboarding.

Position Summary

Ultragenyx is seeking an experienced and highly motivated Sr. Director, Regulatory Affairs - Devices (Gene Therapy), who is a team builder and enjoys a fast paced, dynamic work environment.  The Sr. Director will be responsible for developing and implementing global (US, EU, and other regions) regulatory strategies and processes for in-vitro diagnostics (IVDs)/ companion diagnostics (CDx’s), while also maintaining oversight of these global regulatory strategies for all projects with an IVD/CDX component. The Sr. Director will establish sustainable processes, assure informed relationships, and deliver strategic outcomes.

The responsibilities include providing critical strategic and tactical IVD/CDx global regulatory guidance that positively influences project planning and decision making. The individual will be responsible for developing and maintaining the IVD/CDx strategy template while advising on strategies that are aligned with Ultragenyx gene therapy objectives. The individual will participate in project review meetings and propose ideas to facilitate improved collaboration. The individual will also maintain awareness of the global regulatory environment and assess and communicate impact of changes in the area of personalized medicine, with special focus on diagnostic tests. This position will report to the Vice President of Regulatory Affairs, Gene Therapy.

Responsibilities

    • Maintain oversight of regulatory strategies for all projects with an IVD/CDx component.
    • Develop and maintain the global IVD/CDx strategy, while providing regulatory input to multiple development projects.
    • Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks such as regulatory submissions (e.g. Q-submissions, IDE applications and pre-market filings)
    • Provide IVD/CDx regulatory advice to Early Development Project Leaders, Biomarker Project Leaders, Early Clinical Leaders and the respective late development roles.
    • Review and approval of key regulatory submissions to CDRH (as agreed with diagnostic partners) and corresponding therapeutic dossiers globally.
    • Interacting with EU and international regulatory colleagues and diagnostic partners to determine best practices and lease burdensome regulatory paths towards development and global registration activities.
    • Coordinate and prepare IVD/CDx regulatory documentation in conjunction with diagnostic partners.
    • Coordination with diagnostic partners for IVD documents required for inclusion in drug study Health Authority or EC filings.
    • Maintains awareness of global regulatory environment and monitors key changes in the area of personalized medicine, with special focus on diagnostic tests.
    • Proactively manages critical issues, taking leadership for the regulatory contribution.
    • Supports the development of department policies, processes and SOPs.
    • Provides regulatory due diligence assessments of new business opportunities as required.

Requirements

    • BA/BS Degree required in a health/life sciences or related field. Advanced degree preferred.
    • A minimum of 8 years of IVD, drug-related development or medical research activities and at least 8 years in regulatory affairs.
    • Working knowledge of US, EU (IVDD & IVDR) and international diagnostic regulatory requirements
    • Experienced with FDA interactions and submissions
    • Ideally also experienced with European or international submission
    • Good knowledge of registration files for Medical Devices and/or In Vitro Diagnostics.
    • Good understanding of IVD development process.
    • Excellent operational skills including demonstrated ability in planning, organizing and ability to motivate and lead others.
    • Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders, including Senior Management.
    • Strong negotiating skills and ability to think creatively and develop creative solutions.
    • Strong personal and interpersonal skills, including the ability to relate to and negotiate with others while maintaining composure and acting with integrity and credibility to build trust
    • Ability to deal effectively with a variety of personnel across a matrix organization
    • Strong sensitivity for a multicultural/multinational environment
    • Ability to prioritize and handle multiple projects simultaneously.
    • Sense of urgency and perseverance to achieve results
    • Rare disease and/or gene therapy experience is desirable.
    • Business travel to be ~10-20% as required.
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Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.

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