Senior Director, Regulatory Affairs (Clinical/Non-Clinical Strategy) – Gene Therapy

31 Dec, 2020

Jobs

Senior Director, Regulatory Affairs (Clinical/Non-Clinical Strategy) – Gene Therapy

Ultragenyx
Cambridge, MA
Why Join Us?
Be a hero for our rare disease patients
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 (Clinical/Non-Clinical Strategy), who is a team builder and enjoys a fast paced, dynamic work environment. The Sr. Director will be responsible for providing global regulatory leadership in support of the development, registration, and life-cycle management of our innovative gene therapy programs, as well as for the oversight and mentoring of a growing regulatory team.
The responsibilities include providing leadership and direction for the global regulatory aspects of the gene therapy products, including developing long and short-term planning of regulatory projects that align with the company’s business plan, and developing strategies to ensure effective achievement of regulatory/business objectives. The individual will be responsible for oversite regulatory agencies, corporate partners and vendors in regards to development, regulatory, and registration strategies. The individual will also maintain awareness of the global regulatory environment and assess and communicate impact of changes on business and product development. The position will report to the Vice President of Regulatory Affairs, Gene Therapy.

Responsibilities

    • Provides regulatory leadership in support of the development, registration, and life-cycle management of Ultragenyx products.
    • Guides, coaches and manages a team of regulatory professionals to ensure their professional development and advancement.
    • Provides strategic regulatory direction and mentorship on programs including the overall regulatory plan, regulatory requirements for clinical studies and marketing approval, development plans and study designs, risk assessments, critical issue management and Health Authority interactions.
    • Ensure the successful implementation and execution of regulatory plans to support product approval and commercialization.
    • Uses extensive knowledge of US, EU and ICH regulatory requirements and applies knowledge both strategically and operationally to resolve regulatory issues impacting development programs to ensure business goals are met.
    • Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.
    • Liaises and negotiates with US FDA, Health Canada and other regulatory agencies as needed for all aspects pertaining to drug development including novel regulatory pathways for the company’s gene therapy products, resolution of key regulatory issues and to expedite approvals of products.
    • Approves sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conference with local regulatory requirements.
    • Maintains awareness of global regulatory environment and assesses impact of changes on business and product development programs. Facilitates interpretation of global regulation.
    • 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 13 years in the biotechnology or pharmaceutical industry with at least 8 years of leadership experience managing a regulatory team.
    • Extensive experience in Regulatory including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with Health Authorities, and developing and implementing complex regulatory strategies.
    • Understanding of advanced therapy products and development.
    • Practical understanding and interpretation of applicable ICH, FDA and EMA guidelines and regulations.
    • Strong strategic skills including demonstrated ability to make complex decisions and willingness to defend difficult positions.
    • Strong business acumen and 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 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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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 totalentacquisition@ultragenyx.com.

Job posted: 2020-12-31