Associate Director of Regulatory Affairs, Advertising and Promotion
Locations:
South San Francisco, California
Radnor, Pennsylvania
Time Type: Full Time
Posted On: Posted 2 Days Ago
Job Requisition ID: R85
About Cytokinetics:
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors for treating debilitating diseases caused by impaired cardiac muscle performance. As a leader in muscle biology and mechanics, the company is advancing small molecule drug candidates specifically designed to impact myocardial muscle function and contractility.
Job Purpose:
The Associate Director of Regulatory Affairs, Advertising and Promotion will report directly to the Senior Director, Regulatory Affairs. The primary responsibility is to provide commercial regulatory support for assigned programs and ensure sound regulatory planning and tactical implementation of U.S. promotional strategies. This hybrid role can be based at either the South San Francisco, CA or Radnor, PA location.
Responsibilities:
Functional Area:
Provide commercial regulatory support to assigned products and/or therapeutic areas.
Collaborate with relevant stakeholders to achieve business objectives compliantly.
Develop and guide implementation strategies for promotional activities.
Serve as a member of the Promotional and Medical Review Committees, offering strategic regulatory input during new concept reviews.
Review and approve promotional materials for regulatory compliance.
Assist Commercial Operations in establishing best practices for promotional material submission and review processes.
Formulate regulatory strategies with supervisor oversight, based on regulatory intelligence and scientific knowledge.
Serve as a contact for and maintain positive relationships with the U.S. FDA Office of Prescription Drug Promotion (OPDP).
Prepare and submit promotional materials at the time of dissemination (Form FDA 2253) or for advisory comment requests.
Maintain up-to-date expertise on FDA advertising and promotion regulations and communicate significant changes.
Ensure adherence to feedback from regulatory agencies (e.g., OPDP advisory comments).
Build and maintain relationships across functions and with regulatory health authorities.
Identify, develop, and implement regulatory operating guidelines and common work practices within the team.
Qualifications:
Education:
Bachelor’s degree required, preferably in a scientific discipline.
Advanced degree is a plus.
Experience:
4+ years of Regulatory Affairs experience in Advertising and Promotion.
Deep knowledge of regulatory requirements for compliant advertising/promotion and scientific exchange of prescription drug products, including investigational and post-approval phases.
Experience with product launches preferred.
Familiarity with Veeva PromoMats preferred.
Proven experience working effectively and influencing across teams, functions, and external partners.
Skills:
Excellent oral and written communication skills.
Ability to provide creative solutions based on judgment and analysis of issues.
Strong organizational skills and attention to detail.
Ability to manage multiple priorities and deliver high-quality results under deadlines.
Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $223,250 - $246,750 per year.
Final compensation will consider internal equity, geographic location, job-related skills, and experience.
Commitment to Diversity and Inclusion:
Cytokinetics is committed to building a diverse team. Applicants are encouraged to apply even if they do not meet every qualification. If you are excited about what you could accomplish and believe you can add value, Cytokinetics encourages you to apply.
Important Information:
Cytokinetics emphasizes scientific integrity, patient-centric decisions, and ethical behavior. All legitimate offers will come from an official Cytokinetics email domain (cytokinetics.com) after a formal interview process.
Cytokinetics does not:
Conduct job interviews through non-standard text messaging applications.
Request personal financial information before an offer is accepted.
Ask candidates to purchase equipment during the hiring process.
For verification, contact: talentacquisition@cytokinetics.com.
For more information, visit: www.cytokinetics.com
Equal Opportunity Employer
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