The Director, GRA Global Labeling will be responsible for providing global labeling expertise and direction in support of the development, registration, and lifecycle management of innovative programs for rare diseases. The responsibilities include managing labeling changes for lifecycle products, assisting in the development of labeling content for new products in pre-approval stages, and reviewing applicable regulatory documentation and artwork. You will also support implementation of approved labels which may include document control, QC/proofread, translations and verification of translations, and tracking project milestones and status. You will need a thorough knowledge of global regulations and guidance governing drugs and biologics in all phases of clinical development.

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Provides global labeling leadership in support of the development, registration, and life-cycle management of Ultragenyx products (bofor rare diseases).
• Prepare new and revised labeling content (Company Core Data Sheet, Prescribing Information, Summary of Product Characteristics, Major Market, Patient Information, and Instructions for Use) based on source reports, regulatory requirements, and other reference sources.
• Build strong collaboration with key internal stakeholders, including Global Regulatory leadership team, Clinical Development, Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing,
• Supply Chain, and other functions to support development of draft label text.
• Interact with the cross functional labeling team (Label Working Group and Label Review Committee) to ensure timely implementation of global labeling changes in local product information that are consistent with the company’s position defined in the CCDS and in compliance with local labeling regulations.
• Provide critical review of label documents to ensure key messaging is consistent with program strategy
• Facilitate LWG/LRC/SME meetings to develop content for label documents including resolution of complex label issues and ability to drive consensus utilizing current standard operating procedures, best practices and/or work instructions.
• Facilitate and lead target label strategies with cross functional labeling team incorporating key messaging aligned with target product profile and thorough understanding of competitive landscape environment.
• Manage approved labels in a document label management system to ensure accurate and up-to-date labeling is always available and accessible for global submissions and inspection readiness.
• Contribute to the review and approval of artwork supporting global submissions.
• Implement and maintain a quality control measure during all stages of label development.
• Maintain knowledgebase of current global rules, regulations, and relevant guidance (draft or final) governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s).
• Initiate or contribute to local and/or global process and/or system improvements

Requirements:

• Minimum BA/BS degree in life sciences. Advanced degree preferred.
• A minimum of 8 years’ experience in the biotechnology and/or pharmaceutical industry including at least 5 years in a global regulatory/labeling position.
• Excellent attention to detail with solid coordinating, task planning and time management skills.
• Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability.
• Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making, and implementing plans and risk mitigation strategies.
• Thorough understanding of global drug development regulations and guidelines.
• Willingness to work in a dynamic and changing corporate environment. #LI-CS1 #LI-REMOTE