Director, Regulatory Affairs Advertising and Promotion at Ultragenyx in

Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultraimpact – Make a difference for those who need it most

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 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.

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:

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.

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.
Veeva PromoMats experience preferred.
When needed, ability to travel. #LI-CS1 #LI-Remote

Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · 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

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.