Manager, International Regulatory Affairs

Novato, CA
Ultragenyx – Regulatory Affairs
Full-time

Why Join Us?
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases.  Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
 
Come join our team during this exciting time of growth and opportunities! Our headquarters are located in Novato, CA, 25 miles north of San Francisco, with offices in Brisbane, CA 9 miles south of San Francisco.
 
Position Summary
The Manager, Regulatory Affairs ROW will work closely with the Senior Director, Regulatory Affairs, rest of world (ROW), regulatory colleagues, functional areas, and project teams to support the filings of Ultragenyx drug candidates in markets outside the US and Europe (Rest of the World, ROW). The individual must possess general knowledge of global rules, regulations, and guidances governing the development of drugs and biologics in all phases. The candidate must  have experience with regulatory filings in one region outside the US and Europe, preferably Latin America. Strong verbal and written communication skills are required. 

Responsibilities including, but not limited to:

    • Participate in the development of regulatory strategies for ROW markets and provide strategic input and regulatory advice to the project teams on ROW issues that could impact the development programs
    • Support the preparation and filing of regulatory applications in rest of the world countries
    • Support the preparation of responses to questions from rest of the world Regulatory Authorities
    • Support regulatory post-approval activities
    • Interface with functional areas to identify and obtain information required for regulatory submissions
    • Develop and/or review regulatory documents to ensure that all submissions are of high quality
    • Create and maintain regulatory timelines and track deliverables to timelines to ensure regulatory submission timelines are met.
    • Proactively identify project issues and implement appropriate risk mitigations
    • Support the preparation of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages
    • Maintain knowledge of current global rules, regulations, and guidances governing development of drugs and biologics in all phases of development
    • Support the Senior Director, Reg Affairs, ROW in all activities related to setting up SOPs, procedures and databases for the department

Requirements:

    • BA/BS degree in life sciences or BA/BS degree in any field with working experience in the development of drugs or biologics
    • Strong scientific background with 3-5 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries with at least one year of experience in ROW Regulatory Affairs
    • Thorough understanding of the drug development process and knowledge of global guidances and regulations
    • Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making, and implementing plans and risk mitigation strategies
    • Proven ability to successfully support major submissions and critical projects to deadlines

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.

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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.

#LI-YG1