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Senior Director, Regulatory Affairs - Devices and Diagnostic

Company: Ultragenyx Pharmaceutical
Location: Cambridge
Posted on: February 20, 2021

Job Description:

Senior Director, Regulatory Affairs - Devices and Diagnostics Cambridge, MA / Ultragenyx - Gene Therapy - Regulatory Affairs / Ultragenyx is a commercial-stage biopharmaceutical company committed to developing and commercializing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecules, biologics, gene therapies and nucleic acids to target debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease. Ultragenyx Gene Therapy is headquartered in Cambridge, MA with additional locations in Woburn, MA. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy. Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission - to make a difference in our patients' lives. Come join our team during this exciting time of growth and opportunities!-- 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 process will include remote based web-ex video discussions, interviews & 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. #LI-CZ1 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 . For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed .

Keywords: Ultragenyx Pharmaceutical, Cambridge , Senior Director, Regulatory Affairs - Devices and Diagnostic, Executive , Cambridge, Massachusetts

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