Director, Global Regulatory Affairs - Labeling

April 9

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Ultragenyx

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Ultragenyx is a biopharmaceutical company dedicated to transforming the lives of individuals with rare and ultrarare genetic diseases. The company focuses on developing and delivering treatments for conditions where no current therapies exist, utilizing a variety of drug modalities tailored to each disease. Ultragenyx boasts a robust and diverse clinical pipeline, with therapies in development for genetic diseases such as Wilson Disease, osteogenesis imperfecta, and Angelman Syndrome. With a passionate team and a commitment to patient advocacy, Ultragenyx aims to lead the way in pioneering therapies that significantly impact rare disease communities.

rare disease • ultra-rare disease

501 - 1000 employees

Founded 2010

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• 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 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.

🎯 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.

🏖️ 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