About this Director, Regulatory Affairs Advertising and Promotion role at Ultragenyx Pharmaceutical
Position Summary:
ultrafocused – Work together to fearlessly uncover new possibilities
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.
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:
1. Serve as the MRC Chair and provide direction and regulatory expertise for promotional materials, medical, and payer communications.
2. 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.
3. Review and approve Form FDA-2253 submissions.
4. 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.
5. 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.
6. 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.
7. May lead cross-functional process improvements or other special projects.
8. Represent Regulatory Affairs Ad/Promo at regulatory sub-team and labeling meetings; provide strategic regulatory guidance.
9. Other duties as required.
Requirements:
Requires a BA/BS degree; advanced degree preferred (PharmD, PhD, MS, MBA, JD).
2. 10+ years of industry experience including 5+ years of advertising promotion experience.
3. Excellent verbal and written communication skills.
4. Attention to detail and ability to manage multiple priorities simultaneously.
5. Strong interpersonal skills with ability to demonstrate strategic and analytical thinking.
6. Demonstrate and proactively advocate working together in the spirit of transparency that encourages engagement, collaboration, and respectful interactions.
7. Experience chairing/leading review committees or other relevant regulatory governance committees.
8. Experience participating in cross-functional projects and teams.
9. Strong interpersonal skills and understanding of team dynamics.
10. Veeva PromoMats experience preferred.
11. When needed, ability to travel.
#LI-CS1, #LI-Remote
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
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 [email protected].
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
