Director, Regulatory Affairs Advertising and Promotion

Ultragenyx Pharmaceutical

8d • $214,100 - $264,500 • Remote

About The Position

The Director of Regulatory Affairs Ad/Promo will serve as a subject matter expert for regulatory review of advertising and promotional, and non-promotional materials for the U.S. and Canada (CA) and provide regulatory leadership to the Materials Review Committee (MRC) to ensure all communications, advertising and promotional materials and programs throughout the product life cycle are compliant with applicable laws, regulations, and company policies.

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 ability to demonstrate strategic and analytical thinking.
• Demonstrate and proactively advocate working together in the spirit of transparency that encourages engagement, collaboration, and respectful interactions.
• Experience chairing/leading review committees or other relevant regulatory governance committees.
• Experience participating in cross-functional projects and teams.
• Strong interpersonal skills and understanding of team dynamics.
• When needed, ability to travel.

Nice To Haves

• Veeva PromoMats experience preferred.

Responsibilities

• Serve as the MRC Chair and provide direction and regulatory expertise for promotional materials, medical, and payer communications.
• Serve as primary contact with the FDA (OPDP/APLB) and PAAB as needed, including responding to agency inquiries and managing company requests for advisory review of advertising and promotional material.
• Review and approve Form FDA-2253 submissions.
• Provide strategic and operational regulatory guidance on new concepts, campaigns, and product labeling to help ensure promotional materials are aligned with promotional regulations, corporate standards, and policies and business objectives.
• Support the U.S. and CA commercial and medical teams, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on strategies and objectives and tactics.
• Maintain current awareness of evolving agency regulations and interpretations, FDA advisory letters, enforcement letters and policy issues and trends affecting the industry; communicate significant changes in Agency perspective to relevant stakeholders.
• May lead cross-functional process improvements or other special projects.
• Represent Regulatory Affairs Ad/Promo at regulatory sub-team and labeling meetings; provide strategic regulatory guidance.
• Other duties as required.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director