Director, US Regulatory Affairs, Advertising & Promotion
Cytokinetics•South San Francisco, CA
•$225,000 - $262,500•Hybrid
About The Position
The Director Regulatory Affairs, Advertising and Promotion plays a critical role in providing strategic regulatory leadership and oversight for commercial, promotional, and medical communications. This role ensures that marketing campaigns, disease awareness initiatives, and corporate communications comply with FDA regulations, and company policies. Operating with a high degree of autonomy, the Director collaborates with clinical, medical, and legal to serve as a bridge between commercial tactics and regulatory compliance.
Requirements
- Bachelor’s degree
- Minimum 10 years in pharmaceutical or biotechnology regulatory affairs
- At least 7 years focused on US advertising and promotion
- Proven track record of successful launches for drug or biologic products
- Direct history of managing interactions and submissions with OPDP
- Expert knowledge of FDA regulations governing biologics and promotional compliance
- Proficiency with electronic review systems, specifically Veeva Vault PromoMats.
- Ability to interpret complex clinical data into compliant marketing messages
- Excellent written and verbal communication skills with executive-level stakeholders
- Strong cross-functional collaboration skills to align marketing, medical, and legal stakeholders
Nice To Haves
- PharmD, PhD, or JD
Responsibilities
- Lead regulatory review and approval of U.S. product promotional materials.
- Ensure product claims are supported by FDA-approved labeling and are scientifically substantiated
- Serve as the regulatory advertising and promotion subject matter expert for the organization
- Influence cross-functional decision making through strategic regulatory guidance.
- Mentor junior regulatory professionals and contribute to talent development initiatives
- Lead continuous improvement efforts related to promotional review processes and governance
- Represent regulatory on the MLR Committee, and provide strategic regulatory input during new concept reviews, and review and approve materials for regulatory compliance
- Review non-promotional assets, including medical, corporate affairs, market access/payor communications, and patient advocacy materials
- Develop and update Important Safety Information (ISI) and risk presentations for use in commercial assets for target audiences
- Lead regulatory strategy for OPDP interactions, including advisory comments, enforcement responses, and regulatory correspondence as appropriate
- Manage FDA Form 2253 submissions for applicable commercial assets
- Lead voluntary advisory comment submissions for identified materials
- Monitor OPDP enforcement trends and FDA guidance documents, and communicate relevant updates and learnings with cross functional stakeholders
- Create or update standard operating procedures (SOPs) or work instructions to optimize and streamline work processes
- Train U.S. marketing, sales, and medical affairs teams on regulatory compliance
Benefits
- equity in the form of stock options and/or restricted stock units
- comprehensive health, dental, vision, life and disability insurance coverage
- 401k retirement benefits with employer match
- learning and wellness stipends
- paid time off
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Director
