Director, Regulatory Affairs – Advertising and Promotion

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🔥 12 minutes ago

🇺🇸 United States – Remote

💵 $214.1k - $264.5k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Ultragenyx

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2010

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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.

📋 Description

• Serve as the Materials Review Committee Chair and provide regulatory expertise for promotional materials, medical, and payer communications • Serve as primary contact with the FDA (OPDP/APLB) and PAAB, respond to agency inquiries, and manage requests for advisory review • Review and approve Form FDA-2253 submissions • Provide strategic and operational regulatory guidance on concepts, campaigns, and product labeling • Support U.S. and Canadian commercial and medical teams through strategy discussions and team meetings • Monitor evolving agency regulations, interpretations, advisory letters, enforcement letters, and policy trends • Communicate significant changes in agency perspective to relevant stakeholders • Lead cross-functional process improvements or special projects as needed • Represent Regulatory Affairs Advertising and Promotion at regulatory sub-team and labeling meetings • Provide strategic regulatory guidance and perform other duties as required

🎯 Requirements

• Requires a BA/BS degree; advanced degree preferred (PharmD, PhD, MS, MBA, JD) • 10+ years of industry experience, including 5+ years of advertising promotion experience • Excellent verbal and written communication skills • Attention to detail and ability to manage multiple priorities simultaneously • Strong interpersonal skills with strategic and analytical thinking • Ability to advocate transparent, collaborative, and respectful ways of working • Experience chairing or leading review committees or relevant regulatory governance committees • Experience participating in cross-functional projects and teams • Strong understanding of team dynamics • Veeva PromoMats experience preferred • Ability to travel when needed

🏖️ 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 • Annual bonus • Equity incentives