[Hiring] Associate Director, Global Regulatory Affairs Labeling @Ultragenyx Pharmaceutical

Role Description

The Associate 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.

• Liaise across key functional areas collecting critical regulatory milestones and developing detailed target label strategy plans during clinical development programs.
• Manage labeling changes for lifecycle products.
• Assist in the development of labeling content for new products in pre-approval stages.
• Review applicable regulatory documentation and artwork.
• Support implementation of approved labels, including document control, QC/proofread, translations, and verification of translations.
• Track project milestones and status.
• Possess a thorough knowledge of global regulations and guidance governing drugs and biologics in all phases of clinical development.

Responsibilities

• Provide global labeling leadership in support of the development, registration, and lifecycle management of Ultragenyx products for rare diseases.
• Prepare new and revised labeling content (Company Core Data Sheet, Prescribing Information, Summary of Product Characteristics, Major Market labels, Patient Information, and Instructions for Use) based on source reports, regulatory requirements, and other reference sources.
• Demonstrate the ability to work in a matrix environment communicating label concepts and key messaging during label development consistent with program strategy.
• 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.
• Interact with the cross-functional labeling team (Label Working Group and Label Review Committee) to ensure timely implementation of global labeling changes.
• Prepare, deliver, and/or manage all types of regulatory documents/submissions influencing and managing cross-functional team member input.
• Facilitate LWG/LRC/SME meetings to develop content for label documents.
• Facilitate and lead target label strategies with the cross-functional labeling team.
• Manage approved labels in a document label management system.
• 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 knowledge base of current global rules, regulations, and relevant guidance governing drugs and biologics.
• Initiate or contribute to local and/or global process and/or system improvements.

Qualifications

• Minimum BA/BS degree in life sciences; advanced degree preferred.
• Strong scientific background with 8 years’ experience in the biotechnology and/or pharmaceutical industry, including at least 4+ years in a global regulatory/labeling position.
• Excellent attention to detail with solid coordinating, task planning, and time management skills.
• Excellent verbal, written, and interpersonal communication 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 and implementing plans and risk mitigation strategies.
• Thorough understanding of global drug development regulations and guidelines.
• Willingness to work in a dynamic, fast-paced, and changing corporate environment.

Benefits

• Generous vacation time and public holidays observed by the company.
• Volunteer days.
• Long term incentive and Employee stock purchase plans or equivalent offerings.
• Employee wellbeing benefits.
• Fitness reimbursement.
• Tuition sponsoring.
• Professional development plans.
• Benefits vary by region and country.