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Miles
Km80.5

Associate Director/Director, Regulatory Operations

Ultragenyx Pharmaceutical Inc.

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Location: Novato, CA Posted Date: 5/3/2013 Position Type: Full time Job Code: DIRREGOPS - 20130503 Required Education: High school or equivalent Areas of Expertise Desired: Regulatory Affairs

Description

The Associate Director/Director of Regulatory Operations will lead the Regulatory Operations function.  The Associate Director/Director of Regulatory Operations supervises, prioritizes, and participates in regulatory submission projects.  The Associate Director/Director of Regulatory Operations is the primary contact for Regulatory Operations to Project Teams.  The Associate Director/Director of Regulatory Operations will oversee the development, implementation, and maintenance of electronic submission and document management systems that serve across departments.  The Associate Director/Director of Regulatory Operations will ensure technical compliance with applicable global regulations, specifications, and standard operating procedures for regulatory submissions.  

Responsibilities:

•   Provide leadership, strategic planning and effective management as the Regulatory Operations function evolves, which includes but is not limited to regulatory publishing, archival and tracking.  Responsible for regulatory operations strategy and goals, resource needs and allocation to ensure quality and timely submissions.
•   Manage the Regulatory Operations function, which supports submissions publishing, archiving databases, license tracking tools, and other activities as assigned.  When appropriate, hire, coach, mentor, manage and train team, and ensure effective career development plans are in place for all staff, as assigned.
•   Identify, analyze, and implement applicable industry technologies (including eCTD and EDMS applications) in accordance with applicable regulations, for sustainability and scalability of the organization and propose changes accordingly, including budgetary needs.  Identify issues that will impact programs and provide proactive strategies for dealing with them.  Maintain expert knowledge of electronic submission and computerized system validation standards.
•   Work with Regulatory Affairs and contributing functional areas in establishing submission plans.  Oversee and/or prepare Regulatory submissions globally using internal and external resources.
•   Manage all technical aspects for submissions such as advising authors of required eCTD document granularity, utilization of content templates, style guide, document formatting, eCTD application location, publishing, QC, validation, and transmission to regulatory health authorities.
•   Maintain knowledge of current global regulatory requirements for submission formats.
•   Responsible for tracking and ensuring appropriate archive measures of study reports.
•   Monitor and provide insight into new guidance relevant to regulatory operations.
•   Lead development of SOPs, work process documents, or best practices for global regulatory operations.
•   May serve as regulatory operations representative on cross-functional teams.
•   Other duties as assigned.

Requirements

•   BA/BS degree in life sciences preferred.
•   8+ years of regulatory submissions experience
•   Pharmaceutical industry experience, knowledge of the drug development process, global drug regulations, as related to regulatory operations.
•   Knowledgeable in CTD/eCTD structure and requirements, as well as submission requirements for all submission types globally.
•   Experience filing INDs, NDAs, BLAs, CTAs and MAAs globally.
•   Experience with electronic publishing software and advanced PDF processing tools.
•   Advanced skills in MS Word, MS Excel, MS PowerPoint, and Adobe Acrobat are required.
•   Familiarity with MS Project, MS Visio applications, and XML and SQL specifications is preferred.
•   Experience with electronic document management software, principles of information systems and related technology.
•   Experience with records and/or document management standards.
•   Proven experience of managing and leading teams, including clear ability to coach and mentor.
•   Must be able to work in a fast-paced environment and maintain flexibility while handling multiple priorities.  
•   Shows strong initiative and drive.  Must be an organized self-starter who is able to anticipate departmental needs.
•   Excellent organizational, communication, attention to detail, and time management skills.
•   Excellent interpersonal skills and ability to work successfully within a cross-functional team.
•   Ability to innovate, analyze and solve problems of complex nature with minimal supervision.
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