[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. This individual will liaise across key functional areas collecting critical regulatory milestones and developing detailed target label strategy plans during clinical development programs in order to align with company objectives and registration strategies.

• 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, and tracking project milestones and status.
• Possess a thorough knowledge of global regulations and guidance governing drugs and biologics in all phases of clinical development.

This position will report to Senior Director, GRA Global Labeling.

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

• 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 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.
• 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 including resolution of complex label issues.
• Facilitate and lead target label strategies with cross-functional labeling team incorporating key messaging aligned with target product profile.
• Manage approved labels in a document label management system to ensure accurate and up-to-date labeling is always available.
• 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, identifying risks, decision making in a collaborative way, 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.

Requirements

• 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, identifying risks, decision making in a collaborative way, 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.